NCT06707610 A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK202 in Participants with Advanced Solid Tumors
| NCT ID | NCT06707610 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Shanghai Allink Biotherapeutics Co., Ltd. |
| Condition | Advanced Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 234 participants |
| Start Date | 2025-02-10 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 234 participants in total. It began in 2025-02-10 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06707610 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Advanced Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06707610 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06707610 currently recruiting?
Yes, NCT06707610 is actively recruiting participants. Contact the research team at stduan@allinkbio.com for enrollment information.
Where is the NCT06707610 trial being conducted?
This trial is being conducted at Margate, United States, Fairfax, United States, Randwick, Australia, Sydney, Australia.
Who is sponsoring the NCT06707610 clinical trial?
NCT06707610 is sponsored by Shanghai Allink Biotherapeutics Co., Ltd.. The trial plans to enroll 234 participants.
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