Evaluating ASC61 for advanced solid tumors
An Open-Label, Multicenter, Single-Arm Phase 1 Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC61 in Subjects With Advanced Solid Tumors
This study is testing a new oral medication called ASC61 to see if it can safely help people with advanced solid tumors who don't have other treatment options.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ascletis Pharma Inc Industry-sponsored |
| Locations | 4 sites (Encinitas, California and 3 other locations) |
| Trial ID | NCT05287399 on ClinicalTrials.gov |
What this trial studies
This Phase 1, open-label, multicenter, single-arm study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of ASC61, an orally bioavailable small-molecule inhibitor of PD-L1, in patients with advanced solid tumors who lack standard treatment options. The study will utilize a traditional '3 + 3 design' for dose escalation, starting with an initial dose of 200 mg once daily, followed by potential increases to 200 mg twice daily, 300 mg, 400 mg, and 600 mg. Participants will be enrolled sequentially and monitored for safety and efficacy over 28-day treatment cycles.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with advanced solid tumors that are resistant to standard therapy or for which no standard therapy is available.
Not a fit: Patients with known symptomatic brain metastases, a history of another primary solid tumor, or those who have previously discontinued immune checkpoint therapy due to toxicity may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have exhausted standard therapies.
How similar studies have performed: Other studies involving PD-L1 inhibitors have shown promise, indicating that this approach may be viable, although this specific agent is being evaluated for the first time.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults ≥ 18 years of age at the time of screening * Histological or cytological diagnosis of advanced/metastatic solid tumor that is resistant to standard therapy or for which no standard therapy is available, regardless of cancer stage and previous experienced therapies * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * At least one measurable lesion, as defined by RECIST 1.1 Exclusion Criteria: * Known symptomatic brain metastases requiring steroids * Known history of another primary solid tumor * Subjects discontinued prior therapy with immune checkpoints due to toxicity if previously received therapy with this class of drugs * Known history of idiopathic pulmonary fibrosis, drug-induced pneumonitis, or evidence of active pneumonia or pneumonitis * Gastrointestinal disorders that might affect drug absorption
Where this trial is running
Encinitas, California and 3 other locations
- California Cancer Associates for Research & Excellence (cCARE) — Encinitas, California, United States (Recruiting)
- California Cancer Associates for Research & Excellence (cCARE) — Fresno, California, United States (Recruiting)
- California Cancer Associates for Research & Excellence (cCARE) — San Marcos, California, United States (Recruiting)
- Nebraska Cancer Specialists — Omaha, Nebraska, United States (Recruiting)
Study contacts
- Study coordinator: Ascletis Study Doctor
- Email: clinicaltrials@ascletis.com
- Phone: +86 571 85389730
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.