AD1208 in Subjects With Any Progressive, Locally Advanced or Metastatic Solid Tumors (AD1208)

March 28, 2025 updated by: Avelos Therapeutics Inc.

A Phase I/IIa Trial of AD1208, a Cell Cycle Inhibitor/MASTL Inhibitor, as a Single Agent or a Combination in Subjects With Any Progressive, Locally Advanced(Unresectable) or Metastatic Solid Tumors

The goal of this clinical trial is to evaluate the safety and tolerability of AD1208 to determine the maximum tolerated dose(MTD) or maximumly administered dose(MAD) in any progressive, locally advanced (unresectable) or metastatic solid tumors. The main questions it aims to answer are:

  • Which dosage of AD1208 is safe and tolerable for participants?
  • What medical problems do participants have when taking AD1208?

Participants will:

  • Take drug AD1208 every day up to 1 cycle at the least.
  • Visit the site once every 1 weeks for checkups and tests during cycle 1 and every 3 weeks from cycle 2 onwards.
  • Keep a diary of any adverse events and administrated drug

Study Overview

Status

Status

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

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

- Dose-escalation Part The treatment cycle is defined as 21 days and AD1208 will be administered orally once or twice a day from Day 1 to Day 21 in every 21-day cycle. The dose-escalation part is divided into phase 1a, which determines the Recommended dose of AD1208 in monotherapy, and phase 1b, which determines the RP2D of AD1208 in combination therapy.

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 (Estimated)

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.
36

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center
        • Contact:
        • Contact:
          • Jeeyun Lee
      • Seoul, Korea, Republic of, 03722
        • Recruiting
        • Severance Hospital
        • Contact:
        • Contact:
          • Hyo Song Kim
    • Gyeonggi-do
      • Seongnam, Gyeonggi-do, Korea, Republic of, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
          • Keun-wook Lee
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female subjects ≥19 years of age
  • Willing to consent to participate in study and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
  • Histologically and/or cytologically confirmed any progressive, locally advanced (unresectable), or metastatic solid tumors that have relapsed or are refractory following the last line of treatment and for which prior standard therapy has been ineffective, standard therapy does not exist or is not considered appropriate.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Life expectancy of at least 12 weeks
  • Subjects with adequate hematologic, hepatic, and renal functions confirmed based on the screening laboratory test within 2 weeks prior to the first administration of IP.
  • Female subject who is surgically sterile, is postmenopausal, or agrees to use a highly effective method of birth control (2 methods strongly recommended) during the study and for 6 months following the last dose of IP.
  • Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or for the time the partner is breastfeeding throughout the study period and for 6 months after the final administration of IP.

Exclusion Criteria:

  • Untreated active brain metastases.
  • has leptomeningeal disease.
  • unrecovered > Grade 1 from the adverse event of prior therapy except for alopecia.
  • has an active autoimmune disease requiring systemic treatment within the past 2 years.
  • Active interstitial lung disease (ILD) or pneumonitis or a history of ILD.

  • Subject has received the following treatment;

    • prior anticancer monoclonal antibody treatment or investigational therapy
    • prior any chemotherapy
    • prior radiotherapy
    • Major surgery
  • Clinically significant (i.e., active) cardiovascular disease
  • known positive of human immunodeficiency virus (HIV) infection.
  • Active hepatitis B or C subjects.
  • known allergic reaction for active ingredients or inactive ingredients such as excipients of Investigational product.
  • Live vaccine administered against infectious disease.
  • Gastrointestinal (GI) track disease causing the inability to take oral medication, malabsorption syndrome or uncontrolled inflammatory GI disease.
  • having psychiatric illness/social situations that would limit compliance with study requirements.
  • women with a positive pregnancy test at screening test.
  • women who are breast feeding.
  • subject has any condition because of which, in the opinion of the investigator, the participation would not be in the best interest of the subject.

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: Cohort 1
AD1208 dose 1 (40mg bid) treatment arm
Drug: AD1208
Up to 6 of cohorts will be applied sequentially in phase Ia part.
Experimental: Cohort 2
AD1208 dose 2 (80mg QD) treatment arm
Drug: AD1208
Up to 6 of cohorts will be applied sequentially in phase Ia part.
Experimental: Cohort 3
AD1208 dose 3 (80mg bid) treatment arm
Drug: AD1208
Up to 6 of cohorts will be applied sequentially in phase Ia part.
Experimental: Cohort 4
AD1208 dose 4 (140mg bid) treatment arm
Drug: AD1208
Up to 6 of cohorts will be applied sequentially in phase Ia part.
Experimental: Cohort 5
AD1208 dose 5 (240mg bid) treatment arm
Drug: AD1208
Up to 6 of cohorts will be applied sequentially in phase Ia part.
Experimental: Cohort 6
AD1208 dose 6 (340mg bid) treatment arm
Drug: AD1208
Up to 6 of cohorts will be applied sequentially in phase Ia part.

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
Safety and tolerability
Time Frame: At the end of Cycle 1 (each cycle is 21 days)
to determine maximum tolerated dose (MTD) or maximumly administered dose (MAD)
At the end of Cycle 1 (each cycle is 21 days)

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
Maximum Plasma Concentration [Cmax]
Time Frame: At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
to characterize pharmacokinetic profile of AD1208
At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
A trough level or trough concentration [Ctrough]
Time Frame: At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
to characterize pharmacokinetic profile of AD1208
At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
Time to peak drug concentration [Tmax]
Time Frame: At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
to characterize pharmacokinetic profile of AD1208
At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
Half-life [T1/2]
Time Frame: At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
to characterize pharmacokinetic profile of AD1208
At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
The area under the curve up to the last quantifiable time-point [AUC0-last]
Time Frame: At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
to characterize pharmacokinetic profile of AD1208
At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
Clearance [CL]
Time Frame: At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
to characterize pharmacokinetic profile of AD1208
At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
Volume of distribution at steady state [Vss]
Time Frame: At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
to characterize pharmacokinetic profile of AD1208
At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
objective response rate [ORR]
Time Frame: through study completion, an average of 1 year
to evaluate the preliminary antitumor activity
through study completion, an average of 1 year
disease control rate [DCR]
Time Frame: through study completion, an average of 1 year
to evaluate the preliminary antitumor activity
through study completion, an average of 1 year
treatment duration
Time Frame: through study completion, an average of 1 year
to evaluate the preliminary antitumor activity
through study completion, an average of 1 year
progression-free survival [PFS]
Time Frame: through study completion, an average of 1 year
to evaluate the preliminary antitumor activity
through study completion, an average of 1 year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
metabolite 6 [M6]
Time Frame: At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
to profile the metabolites of AD1208
At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
metabolite 8 [M8]
Time Frame: At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
to profile the metabolites of AD1208
At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
metabolite 9 [M9]
Time Frame: At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
to profile the metabolites of AD1208
At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
metabolite 10 [M10]
Time Frame: At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
to profile the metabolites of AD1208
At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
metabolite 11 [M11]
Time Frame: At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
to profile the metabolites of AD1208
At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
metabolite 12 [M12]
Time Frame: At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
to profile the metabolites of AD1208
At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
PPP2R2A
Time Frame: baseline, pre-intervention/procedure/surgery
to investigate Potential predictive biomarker related to AD1208
baseline, pre-intervention/procedure/surgery

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.
Avelos Therapeutics Inc.

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.
March 11, 2025

Primary Completion (Estimated)

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.
June 30, 2029

Study Completion (Estimated)

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.
February 20, 2030

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).
March 17, 2025

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.
March 28, 2025

First Posted (Actual)

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.
April 4, 2025

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.
April 4, 2025

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.
March 28, 2025

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.
March 1, 2025

More Information

Terms related to this study

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.
  • AVS1001-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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