QUILT-2.008: Study of ALT-801 With Cisplatin in Patients With Metastatic Melanoma

August 18, 2026 updated by: Altor BioScience

Phase Ib/II Study of ALT-801 With Cisplatin in Patients With Metastatic Melanoma

This is a Phase Ib/II, open-label, multi-center, competitive enrollment and dose-escalation study of ALT-801 combined with cisplatin. The purpose of this study is to evaluate the safety, determine the Maximum-Tolerated Dose (MTD), and characterize the pharmacokinetic profile of ALT-801 given with cisplatin in patients who are chemotherapy naïve and have metastatic melanoma that is considered surgically incurable. The anti-tumor responses of ALT-801 with cisplatin will also be assessed in this trial.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Most current cancer treatment strategies involve the use of chemotherapeutic or biological drugs that exhibit variable efficacy and considerable toxicity. The limitations are often the result of the adverse side effects of the therapeutic drug on normal tissues. One approach to control these effects is to target the therapy to the tumor site. Of the identified tumor antigens, the human p53 tumor suppressor protein is overexpressed in a wide range of human malignancies. p53 is an intracellular tumor suppressor protein that acts to arrest the proliferation of cells. When mutated, it loses its ability to suppress abnormal proliferation and exhibits a longer half-life than the wild-type protein, allowing for its accumulation in tumors. In addition, p53 overexpression correlates with tumor transformation and aggression and is associated with lower overall survival rates and resistance to chemotherapeutic intervention in cancer patients. Therefore, p53 appears to be a marker for a considerable number of human malignancies and represents a good target for immunotherapeutics. However, p53 cannot be used as a target for antibodies because it is not displayed independently on the cell surface. Instead, the p53 protein is processed intracellularly into peptide fragments that are then displayed on the cell surface in the context of MHC. These peptide/MHC complexes are recognized by T-cells via their T-cell receptors (TCRs). Recently it has been confirmed that a p53 peptide fragment is significantly elevated in a wide range of human tumor tissues, particularly in melanoma, renal, lung, breast, colorectal, and osteosarcoma cancers. As a result, the feasibility of using soluble TCRs to target therapies against tumor cells that overexpress p53 is being investigated.

Interleukin-2 (IL-2) is a well-characterized growth factor for immune effector cells which play critical roles in tumor control and rejection. As a result, recombinant human IL-2 (e.g., Proleukin®, Chiron Novartis) has been approved for treatment of metastatic melanoma and renal cell carcinoma. IL-2 treatment provides significant benefit to a subset of patients with some maintaining durable responses for over ten years post-treatment. However, the major drawbacks of IL-2 therapy are its limited half-life and severe systemic toxicity. Hence, the use of high dose IL-2 is limited to specialized programs with experienced personnel, and it is generally offered to patients who are responsive and have excellent organ function. The low dose IL-2 treatment, while less toxic and more convenient, produces lower response rates and appears to be less effective in treating metastatic tumors. Thus, there is a critical need for innovative strategies that enhance the effects of IL-2 or reduce its toxicity without compromising clinical benefit. Targeted approaches to concentrate therapeutic cytokines, such as IL-2, at the tumor sites that express p53 could provide considerable advantages over current treatment.

The study drug, ALT-801, is a biologic compound composed of interleukin-2 (IL-2) genetically fused to a humanized soluble T-cell receptor directed against the p53-derived peptides expressed on tumor cells. This study is to evaluate whether directing IL-2 activity using ALT-801 to the patient's tumor sites that overexpress p53 results in clinical benefits if the ALT-801 treatment is given with cisplatin.

Platinum-based analogues including cisplatin, alone or in combination with other chemotherapies, have been shown to be active in patients with metastatic melanoma. Additionally, it is known that cisplatin, an alkylating agent known to inhibit DNA synthesis of dividing cells, triggers increased intracellular level of p53. The synergistic effects of cisplatin and ALT-801 treatment may induce cisplatin-mediated increases in p53 peptide display on the tumors and subsequently enhance tumor targeting of ALT-801.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90025
        • The Angeles Clinic and Research Institute
    • Florida
      • Orlando, Florida, United States, 32806
        • MD Anderson Cancer Center Orlando
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Carolinas Medical Center-Brumenthal Cancer Center
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • St. Luke's Hospital and Health Network
    • Washington
      • Seattle, Washington, United States, 98109
        • University of Washington, Seattle Cancer Care Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

ENTRY CRITERIA:

DISEASE CHARACTERISTICS:

  • Locally advanced or metastatic melanoma
  • Measurable
  • Histologically or cytologically confirmed
  • Surgically incurable
  • HLA-A2 positive and tumors that present HLA-A2.1/p53aa264-272 complexes

PRIOR/CONCURRENT THERAPY:

  • If prior Proleukin treatment, must have had clinical benefit
  • No prior systemic cytotoxic chemotherapy for melanoma
  • No concurrent radiotherapy, chemotherapy, or other immunotherapy
  • More than 4 weeks since prior major radiotherapy
  • More than 8 weeks since prior CTLA-4 antagonist immunotherapy
  • Not receiving other investigational agents

PATIENT CHARACTERISTICS:

Life expectancy

  • > 3 months

Performance status

  • ECOG 0 or 1

Bone marrow reserve

  • Absolute neutrophil count (AGC/ANC) ≥ 1,500/uL
  • Platelets ≥100,000/uL
  • Hemoglobin ≥ 10g/dL

Renal function

  • Serum creatinine ≤ 1.5 mg/dL

Hepatic function

  • Total bilirubin ≤ 1.5 X ULN
  • AST ≤ 2.5 X ULN
  • Alkaline phosphatase ≤ 2.5 X ULN
  • PT INR ≤ 1.5 X ULN
  • aPTT ≤ 1.5 X ULN

Cardiovascular

  • May be safely tapered off anti-hypertensives if currently on anti-hypertensives
  • New York Heart Association classification I or II
  • No congestive heart failure <6 months
  • No unstable angina pectoris <6 months
  • No myocardial infarction <6 months
  • No history of ventricular arrhythmias

  • Normal cardiac stress test required if any of the following is present:

    • Age ≥ 50
    • History of abnormal EKG
    • Symptoms of cardiac ischemia or arrhythmia

Pulmonary

  • Normal pulmonary function test (FEV1 ≥ 70% of predicted value) if any of the following is present:

    • Prolonged history of cigarette smoking
    • Symptoms of respiratory dysfunction

Other

  • No known autoimmune disease
  • No known HIV positive
  • No psychiatric illness/social situations that would limit study compliance
  • No history or evidence of CNS disease
  • No active systemic infection requiring parental antibiotic therapy
  • No systemic steroid therapy required
  • No prior organ allograft or allogeneic transplantation
  • Not receiving chronic medication for asthma
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ALT-801 - 0.04 mg/kg + cisplatin

Intravenous infusions; cycle 1: day 3 and 5; cycle 2: day 1, 3 and 5; nine day rest period between cycles; seven day recovery period between courses.

Participants received cisplatin 70 mg/m^2 on cycle 1 day 1 only.
Drug: Cisplatin
Participants receive cisplatin 70 mg/m^2 on cycle 1 day 1 only.
Biological: ALT-801

Intravenous infusions; cycle 1: day 3 and 5; cycle 2: day 1, 3 and 5; nine day rest period between cycles; seven day recovery period between courses

Stage 1: dose escalation (0.04 mg/kg, 0.06 mg/kg, 0.08 mg/kg, 0.10 mg/kg)

Stage 2: dose expansion (dose at MTD)
Experimental: ALT-801 - 0.06 mg/kg + cisplatin

Intravenous infusions; cycle 1: day 3 and 5; cycle 2: day 1, 3 and 5; nine day rest period between cycles; seven day recovery period between courses.

Participants received cisplatin 70 mg/m^2 on cycle 1 day 1 only.
Drug: Cisplatin
Participants receive cisplatin 70 mg/m^2 on cycle 1 day 1 only.
Biological: ALT-801

Intravenous infusions; cycle 1: day 3 and 5; cycle 2: day 1, 3 and 5; nine day rest period between cycles; seven day recovery period between courses

Stage 1: dose escalation (0.04 mg/kg, 0.06 mg/kg, 0.08 mg/kg, 0.10 mg/kg)

Stage 2: dose expansion (dose at MTD)
Experimental: ALT-801 - 0.08 mg/kg + cisplatin

Intravenous infusions; cycle 1: day 3 and 5; cycle 2: day 1, 3 and 5; nine day rest period between cycles; seven day recovery period between courses.

Participants received cisplatin 70 mg/m^2 on cycle 1 day 1 only.
Drug: Cisplatin
Participants receive cisplatin 70 mg/m^2 on cycle 1 day 1 only.
Biological: ALT-801

Intravenous infusions; cycle 1: day 3 and 5; cycle 2: day 1, 3 and 5; nine day rest period between cycles; seven day recovery period between courses

Stage 1: dose escalation (0.04 mg/kg, 0.06 mg/kg, 0.08 mg/kg, 0.10 mg/kg)

Stage 2: dose expansion (dose at MTD)
Experimental: ALT-801 - 0.10 mg/kg + cisplatin

Intravenous infusions; cycle 1: day 3 and 5; cycle 2: day 1, 3 and 5; nine day rest period between cycles; seven day recovery period between courses.

Participants received cisplatin 70 mg/m^2 on cycle 1 day 1 only.
Drug: Cisplatin
Participants receive cisplatin 70 mg/m^2 on cycle 1 day 1 only.
Biological: ALT-801

Intravenous infusions; cycle 1: day 3 and 5; cycle 2: day 1, 3 and 5; nine day rest period between cycles; seven day recovery period between courses

Stage 1: dose escalation (0.04 mg/kg, 0.06 mg/kg, 0.08 mg/kg, 0.10 mg/kg)

Stage 2: dose expansion (dose at MTD)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To Evaluate the Safety of ALT-801-cisplatin Regimen by the Number of Participants With AEs.
Time Frame: Up to 12 months
Safety was measured by the number of participants experiencing a treatment emergent adverse event [AE]
Up to 12 months
To Assess the Objective Response (OR) Which Includes CR and PR
Time Frame: 3 months
The objective response rate (ORR) was calculated as the ratio of the number of patients who demonstrated a confirmed response (complete response [CR] or partial response [PR]) divided by the number of patients evaluable for response based on Response Evaluation Criteria in Solid Tumors Criteria (RECIST) v1.1. Per RECIST v1.1, a Complete Response (CR) is disappearance of all target lesions; Partial Response (PR) is >= 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; and Overall Response (OR) = CR + PR.
3 months
To Assess the Clinical Benefit (CB) of the ALT-801-Cisplatin Regimen Which Includes CR, PR and SD
Time Frame: 3 months
The clinical benefit rate (CBR) was calculated as the ratio of the number of patients who demonstrated a response (confirmed CR, confirmed PR, or stable disease [SD] lasting ≥ 8 weeks) divided by the number of patients evaluable for response.
3 months
To Determine the MTD of the ALT-801-Cisplatin Regimen Determined by Number of Participants With DLTs
Time Frame: 7 weeks
The MTD was determined based on a 3x3 design based on the number of participants with at least 1 Dose Limiting Toxicity (DLT) Adverse Event.
7 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To Assess the Six-month and One-year Survival Rates.
Time Frame: 12 months

Survival was analyzed using Kaplan-Meier (KM) methods. Overall survival (OS) was defined as the time from start of study treatment to the date of death (any cause).

Participants who were alive at the end of follow-up will be censored in the OS analysis at the last known date alive. The 6-month and 1-year survival probability rates were estimated from the KM analysis.
12 months
Phase 2 Only: To Evaluate the Immunogenicity and Pharmacokinetic Profile of ALT-801
Time Frame: 2 months
Blood samples for pharmacokinetic (PK) analysis of ALT-801 were to be taken on the first dose of ALT-801 of each course of study treatment. On each sampling day, venous blood was to be obtained at Time 0 (before the start of infusion), at 30 min (15 min after completion of drug infusion), and 1 hr, 3 hr, and 6 hr from Time 0 for the assessment of ALT-801 serum concentration. Non-compartmental and compartmental analyses were to be conducted. Serum levels of IFNγ and TNFα were also to be evaluated using the same blood samples and at the same schedule as PK analysis. The cell-mediated immune responses were to be evaluated once each treatment cycle in the predosing blood samples of the first ALT-801 infusion.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Altor BioScience

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Hing Wong, PhD, Altor BioScience

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 9, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2009

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 10, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA-ALT-801-02-09
  • R44CA097550 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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