Study of ACR246 in Advanced Solid Tumors

Advanced Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06238401
• Other study ID #: ACR246-101
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: March 1, 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: January 2024
• Source: Hangzhou Adcoris Biopharmacy Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 77
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• ACR246 for injection
80 mg/vial

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou Adcoris Biopharmacy Co., Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability:	Incidence and characteristics of adverse events (AEs), serious adverse events (SAEs) and dose-limiting toxicities (DLTs).	21days
Secondary	PK parameters of ACR246(Cmax)	To assess the pharmacokinetic profile in patients with advanced solid tumors	21days
Secondary	PK parameters of ACR246(Tmax)	To assess the pharmacokinetic profile in patients with advanced solid tumors	21days
Secondary	PK parameters of ACR246(t1/2)	To assess the pharmacokinetic profile in patients with advanced solid tumors	21days
Secondary	PK parameters of ACR246(AUC0-t)	To assess the pharmacokinetic profile in patients with advanced solid tumors	21days
Secondary	PK parameters of ACR246(AUC0-8)	To assess the pharmacokinetic profile in patients with advanced solid tumors	21days
Secondary	PK parameters of ACR246(CL)	To assess the pharmacokinetic profile in patients with advanced solid tumors	21days
Secondary	PK parameters of ACR246(Vd)	To assess the pharmacokinetic profile in patients with advanced solid tumors	21days
Secondary	PK parameters of ACR246(mean residence time (MRT))	To assess the pharmacokinetic profile in patients with advanced solid tumors	21days