HS-20110 with bevacizumab and chemotherapy for advanced colorectal cancer
A Phase Ib/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-20110 Combination Therapies in Patients With Advanced Colorectal Cancer.
This trial will test whether adding HS-20110 to bevacizumab plus standard chemotherapy helps adults with advanced colorectal cancer.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 502 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hansoh BioMedical R&D Company Industry-sponsored |
| Locations | 1 site (Guangzhou) |
| Trial ID | NCT07283367 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, open-label Phase Ib/II study using a Rolling 6 dose-escalation design to find the recommended phase II dose (RP2D) of HS-20110 given with bevacizumab and standard chemotherapy backbones. Three cohorts combine HS-20110 with bevacizumab plus 5-FU/leucovorin, bevacizumab plus oxaliplatin and 5-FU/leucovorin, or bevacizumab plus oxaliplatin and capecitabine. After the RP2D is identified in Phase Ib, a Phase II expansion will further test safety, tolerability, pharmacokinetics, and anti-tumor activity in patients with metastatic colorectal cancer. The study enrolls adults with pathologically confirmed colorectal cancer who are non-MSI-H and without BRAF V600E mutation and requires at least one measurable lesion per RECIST 1.1.
Who should consider this trial
Good fit: Adults (≥18) with pathologically confirmed advanced/metastatic colorectal cancer who are non-MSI-H, lack BRAF V600E mutation, and have at least one RECIST 1.1 target lesion are the intended participants.
Not a fit: Patients with MSI-H or BRAF V600E mutations, only CNS lesions, recent anti-cancer therapy or major surgery, recent extensive radiotherapy, or current use of strong CYP450 inhibitors/inducers are unlikely to qualify or benefit from this protocol.
Why it matters
Potential benefit: If successful, adding HS-20110 could improve tumor control or response when combined with bevacizumab and standard chemotherapy.
How similar studies have performed: Combining targeted agents with bevacizumab and chemotherapy has shown benefit in some colorectal cancer settings, but HS-20110 itself appears to be a novel agent without published large-scale efficacy results yet.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Males or females, aged ≥ 18 years. * Participants with pathologically confirmed advanced Colorectal Cancer. * Participants have at least 1 target lesion other than CNS lesions according to RECIST 1.1. * MSI was tested to be non-MSI-H, and without BRAF V600E mutation. Exclusion Criteria: * Participants have received or are receiving the following treatment: 1. Anti-tumor drugs within 14 days prior to the first dose of study treatment; any other IMPs or macromolecular anti-tumor drugs within 28 days prior to the first dose of study treatment. 2. Local radiotherapy within 2 weeks prior to the first dose of study treatment; irradiation of more than 30% of bone marrow or extensive radiotherapy within 4 weeks prior to the first dose of study treatment. 3. Major surgery within 4 weeks prior to the first dose of study treatment. 4. Participants previously treated with drugs that are moderate to strong inhibitors or moderate to strong inducers of cytochrome P450 (CYP) 3A4, strong inhibitors or strong inducers of CYP2D6, P-glycoprotein (P-gp), breast cancer resistance protein (BCRP) or drugs with a narrow therapeutic range that are sensitive substrates of P-gp or BCRP within 7 days prior to the first dose of the IMP. Participants who need to receive these drugs during the study period should also be excluded. 5. Current use of drugs known to prolong the QT interval or that may cause torsade de pointes. Participants who need to receive these drugs during the study period should also be excluded. 6. Live vaccine or live-attenuated vaccine within 28 weeks prior to the first dose. * Participants who have any Grade ≥ 2 residual toxicity according to Common Terminology Criteria for Adverse Events (CTCAE, version 5.0) from prior therapies (except alopecia and residual neurotoxicity). * Inadequate bone marrow reserve or hepatic and renal functions. * Participants with a history of severe allergy (such as anaphylactic shock), previous severe infusion reactions, or allergy to recombinant human or murine proteins. * Participants who are allergic to any component of HS-20110 combination therapies.
Where this trial is running
Guangzhou
- Sun Yat-sen University Cancer Center — Guangzhou, China (Recruiting)
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.