Recruiting
Phase 1

ALK202

Sponsor:

Shanghai Allink Biotherapeutics Co., Ltd.

Code:

NCT06707610

Conditions

Advanced Cancer

Advanced Solid Tumor

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

ALK202

Study Details

Brief summary:

TThis is a first-in-human (FIH), open-label, multicenter dose escalation and expansion study of ALK202. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of ALK202 as a monotherapy in adult participants with Advanced Solid Tumors. The study will also identify recommended dose(s) for subsequent clinical studies of ALK202.

Conditions

Advanced Cancer

Advanced Solid Tumor

Study ID

NCT06707610

Start date

Feb 10, 2025

Status verified date

Mar, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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
  • 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 (abstinence, birth control pills, barrier contraception, intra-uterine contraceptive device, etc.) from the date of signing the ICF until at least 6 months after the last dose of ALK202, and during this period, male participants are not allowed to donate sperms.

Exclusion Criteria:

  • Received organ transplant or hematopoietic stem cell transplant previously
  • Vaccinated with live vaccines within 4 weeks prior to the first dose
  • Primary central nervous system malignancies, or active metastases to central nervous system and/or metastases to meninges
  • Pregnant or lactating women
  • Pleural effusion, pericardial effusion, or intraperitoneal effusion accompanied with clinical symptoms, clinically poorly controlled, or requiring repeated drainage.
  • Evidence of other severe or uncontrolled systemic diseases (e.g., decompensated respiratory disorder, hepatic disease, or renal disease).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Enrollment

234 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A: Dose-escalation Phase Part B: Dose-expansion Phase

A dose-escalation study to determine the MTD and the subsequent doses for dose expansion study (Part B). A dose-expansion study which will enroll the select indications.

Interventions

ALK202

Administered intravenously, once every 3 weeks

Primary outcome measure

  • To evaluate the safety and tolerability of ALK202 in adult participants with advanced solid tumors; To determine the maximum tolerated dose (MTD); To determine the recommended dose(s) of ALK202 for subsequent clinical studies. [ Time Frame: Approximately 36 months ]

Central Contacts and Locations

Central contacts

Shuntong Duan

8618005141727stduan@allinkbio.com

Locations

D&H Cancer Research Center Llc

Recruiting

Margate, Florida, United States, 33063

Contacts

Dr. David Kahn

+1 9543232422Drdkahn@dhnrc.com

Next Oncology

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Dr. Alex Apira

+1 7032805390aspira@nextoncology.com

More Information

Sponsor

Shanghai Allink Biotherapeutics Co., Ltd.

Last update posted

Mar 12, 2025

Last verified

Mar, 2025

Keywords

  • First-in-human

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Shanghai Allink Biotherapeutics Co., Ltd. on 2025-03-12.