A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK201 in Participants With Advanced Solid Tumors

Phase 2RecruitingNCT06656390

Shanghai Allink Biotherapeutics Co., Ltd.202 enrolled

Overview

This is a first-in-human (FIH), open-label, multicenter dose escalation and expansion study of ALK201. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of ALK201 as a monotherapy in adult participants with Advanced Solid Tumors. The study will also identify recommended dose(s) for subsequent clinical studies of ALK201.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

202

Conditions

Advanced Cancer Advanced Solid Tumors

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Men and women ≥18 and ≤75 years old on the day of signing the ICF * At least 1 measurable lesion per RECIST v1.1 * Expected survival ≥3 months * Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1 * Adequate organ function * Female participants of childbearing potential or male participants whose partner is a female of childbearing potential agree to use medically effective contraceptive methods from the date of signing the ICF until at least 6 months after the last dose of the IP, and during this period, male participants are not allowed to donate sperms Exclusion Criteria: * Active or pre-existing autoimmune diseases that may relapse * Pleural effusion, pericardial effusion, or intraperitoneal effusion accompanied with clinical symptoms, clinically poorly controlled, or requiring repeated drainage * Allergies to any component of ALK201 or other monoclonal antibodies * Primary central nervous system malignancies, or active metastases to central nervous system and/or metastases to meninges * Combined with ≥ Grade 2 stomatitis and/or nose bleeding at screening * Vaccinated with live vaccines within 4 weeks prior to the first dose Note: Other protocol defined Inclusion/Exclusion criteria may apply

Locations (38)

Denver Drug Development Unit

Denver, Colorado, United States

RECRUITING

UCF Lake Nona Cancer Center

Orlando, Florida, United States

RECRUITING

University Medical Center New Orleans

New Orleans, Louisiana, United States

RECRUITING

Sarah Cannon Research Institute Oncology Partners

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

To evaluate the safety and tolerability of ALK201 in adult participants with advanced solid tumors; To determine the maximum tolerated dose (MTD); To determine the recommended dose(s) of ALK201 for subsequent clinical studies.

Dose-limiting toxicity (DLT); The incidence and severity of treatment-emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs) according to CTCAE v5.0.