NCT07283367 A Phase Ib/II Trial of HS-20110 Combination Therapies in Advanced Colorectal Cancer Patients.
| NCT ID | NCT07283367 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Hansoh BioMedical R&D Company |
| Condition | CRC |
| Study Type | INTERVENTIONAL |
| Enrollment | 502 participants |
| Start Date | 2025-12-22 |
| Primary Completion | 2029-12-31 |
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 502 participants in total. It began in 2025-12-22 with a primary completion date of 2029-12-31.
⚠ 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
This is a multicenter, open-label Phase Ib/II clinical study evaluating the safety, tolerability, pharmacokinetics (PK), and efficacy of the HS-20110 combination therapies in Patients with Advanced Colorectal Cancer. "Rolling 6" design would be used to conduct dose escalation part of this study. This study consists of phase Ib and phase II. After RP2D was determined in phase Ib, then a phase II study will be conducted to further evaluate the efficacy, safety, tolerability, and PK of the HS-20110 combination therapies in Patients with mCRC.
Eligibility 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.
Frequently Asked Questions
Who can join the NCT07283367 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying CRC. 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 NCT07283367 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 NCT07283367 currently recruiting?
Yes, NCT07283367 is actively recruiting participants. Visit ClinicalTrials.gov or contact Hansoh BioMedical R&D Company to inquire about joining.
Where is the NCT07283367 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07283367 clinical trial?
NCT07283367 is sponsored by Hansoh BioMedical R&D Company. The trial plans to enroll 502 participants.