Testing HS-20117 with other drugs for advanced solid tumors

Safety, Tolerability, Efficacy, Pharmacokinetics Profile and Immunogenicity of HS-20117 in Combination With Other Drugs in Advanced Solid Tumors, a Phase Ib Clinical Trial

This study is testing a new drug called HS-20117, along with other treatments, to see if it can help people with advanced solid tumors like non-small cell lung cancer and colorectal cancer.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 780 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Hansoh BioMedical R&D Company (industry)
• Locations: 1 site (Tianjin)
• Trial ID: NCT06621563 on ClinicalTrials.gov

What this trial studies

This Phase Ib clinical trial evaluates the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of HS-20117, a bispecific antibody, in combination with various treatments for patients with advanced solid tumors. The study is multicenter and open-label, featuring both dose escalation and dose expansion phases. Participants will receive HS-20117 in combination with other therapies, including chemotherapy, to assess its effectiveness against specific types of non-small cell lung cancer and colorectal cancer.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with unresectable, recurrent, or metastatic solid tumors and an ECOG performance status of 0-1.

Not a fit: Patients who have previously received treatments targeting MET or EGFR, or those currently undergoing other anticancer therapies, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with advanced solid tumors.

How similar studies have performed: Other studies have shown promise with similar bispecific antibody approaches, but this specific combination is novel.

Eligibility criteria

Inclusion Criteria:

* Males or females aged 18 - 75 years (inclusive).
* Histologically confirmed unresectable, recurrent or metastatic solid tumors.
* At least one target lesion per the RECIST v1.1.
* ECOG performance status of 0-1.
* Minimum life expectancy \> 12 weeks.
* Males or Females should be using adequate contraceptive measures throughout the study.
* Females must not be pregnant at screening or have evidence of non-childbearing potential.
* Signed Informed Consent Form.

Exclusion Criteria:

* Received or are receiving the following treatments:

  1. Any anticancer therapy targeting MET, including TKIs, antibodies or antibody-drug conjugates.
  2. Monoclonalor bispecific antibodies targeting EGFR.
  3. Systemic anti-cancer treatment (Cytotoxicities and anti-cancer Traditional Chinese medicine or TKIs) within 2 weeks prior to the first dose of HS-20117.
  4. Investigational anti-cancer drugs or antibodies or ADCs within 4 weeks prior to the first dose of HS-20117.
  5. Local radiotherapy within 2 weeks prior to the first dose of HS-20117, more than 30% of bone marrow irradiation or large-area radiotherapy within 4 weeks before the first dose of HS-20117.
  6. Presence of pleural effusion/ascites requiring clinical intervention; presence of pericardial effusion.
  7. Major surgery within 4 weeks prior to the first dose of HS-20117.
* Presence of Grade ≥ 2 toxicities due to prior anti-tumor therapy.
* Presence of uncured secondary primary malignancies.
* Untreated, or active central nervous system metastases.
* Severe, uncontrolled or active cardiovascular disorders.
* Serious infection within 4 weeks prior to the first dose of HS-20117.

Where this trial is running

Tianjin

• Tianjin Medical University Cancer Institute & Hospital — Tianjin, China (RECRUITING)

Study contacts

• Study coordinator: Xiaowei Yan

Conditions: Solid Tumors, Non-Small Cell Lung Cancer, Colorectal Cancer, Solid tumor, EGFR/c-MET bispecific antibody, B7H3 ADC, chemotherapy