Study of ACR246 in Advanced Solid Tumors

February 1, 2024 updated by: Hangzhou Adcoris Biopharmacy Co., Ltd

An Open-label, Multicenter, Dose-escalation and Cohort Expansion Phase I/II.a Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Efficacy of ACR246 in Patients With Advanced Solid Tumors

The goal of the study is to evaluate the safety and tolerability of ACR246 in patients with advanced solid tumors, to determine the maximum tolerated dose (MTD) and Phase II recommended dose (RP2D) of ACR246.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

77

Phase

  • Phase 1

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1. Voluntarily signed the informed consent form (ICF), understands the study and is willing to follow and have the ability to complete all trial procedures;
  • 2, For Phase I dose escalation phase: Patients with histologically or cytologically confirmed recurrent or metastatic unresectable advanced solid tumors who have failed or cannot tolerate systemic standard therapy, or have no standard therapy;
  • 3, The central laboratory test is positive for 5T4;
  • 4, Subjects had at least one evaluable lesion on imaging according to the Efficacy Evaluation Criteria for Solid Tumors (RECIST) v1.1;
  • 5, Toxicity from prior anti-tumor therapy has recovered to Grade ≤1 as defined by NCI-CTCAE v5.0;
  • 6, ECOG≤1;
  • 7, Adequate bone marrow, liver, kidney and blood coagulation function.

Exclusion Criteria:

  • Other primary malignant tumors;
  • Received any systemic anti-tumor therapy within 4 weeks prior to the first dose
  • Prior treatment with any 5T4-targeted drug therapy;
  • Patients with active brain metastases or spinal cord metastases;
  • Known hypersensitivity to any of the active ingredients or excipients of ACR246;
  • History of severe heart disease;

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ACR246 for injection
Administered by intravenous infusion on Day 1 every 3 weeks (Q3W).
Drug: ACR246 for injection
80 mg/vial

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability:
Time Frame: 21days
Incidence and characteristics of adverse events (AEs), serious adverse events (SAEs) and dose-limiting toxicities (DLTs).
21days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PK parameters of ACR246（Cmax）
Time Frame: 21days
To assess the pharmacokinetic profile in patients with advanced solid tumors
21days
PK parameters of ACR246（Tmax）
Time Frame: 21days
To assess the pharmacokinetic profile in patients with advanced solid tumors
21days
PK parameters of ACR246（t1/2）
Time Frame: 21days
To assess the pharmacokinetic profile in patients with advanced solid tumors
21days
PK parameters of ACR246（AUC0-t）
Time Frame: 21days
To assess the pharmacokinetic profile in patients with advanced solid tumors
21days
PK parameters of ACR246（AUC0-∞）
Time Frame: 21days
To assess the pharmacokinetic profile in patients with advanced solid tumors
21days
PK parameters of ACR246（CL）
Time Frame: 21days
To assess the pharmacokinetic profile in patients with advanced solid tumors
21days
PK parameters of ACR246（Vd）
Time Frame: 21days
To assess the pharmacokinetic profile in patients with advanced solid tumors
21days
PK parameters of ACR246（mean residence time (MRT)）
Time Frame: 21days
To assess the pharmacokinetic profile in patients with advanced solid tumors
21days

Collaborators and Investigators

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

Sponsor

Hangzhou Adcoris Biopharmacy Co., Ltd

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 (Estimated)

March 1, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

January 17, 2024

First Submitted That Met QC Criteria

February 1, 2024

First Posted (Actual)

February 2, 2024

Study Record Updates

Last Update Posted (Actual)

February 2, 2024

Last Update Submitted That Met QC Criteria

February 1, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACR246-101

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

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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