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Trial Title:
Phase Ib Trial of HS-20117 in Combination with Other Drugs in Advanced Solid Tumors
NCT ID:
NCT06621563
Condition:
Solid Tumors
Non-Small Cell Lung Cancer
Colorectal Cancer
Conditions: Official terms:
Neoplasms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
Solid tumor
EGFR/c-MET bispecific antibody
B7H3 ADC
chemotherapy
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
HS-20117 combined HS-20093
Description:
HS-20117 + HS-20093
Arm group label:
Cohort B
Arm group label:
Cohort E1
Arm group label:
Cohort E2
Intervention type:
Drug
Intervention name:
HS-20117 combined Platinum-containing chemotherapy
Description:
HS-20117 + cisplatin/carboplatin + pemetrexed
Arm group label:
Cohort A
Arm group label:
Cohort D1
Arm group label:
Cohort D2
Intervention type:
Drug
Intervention name:
HS-20117 combined HS-20093 and 5-FU
Description:
HS-20117 + HS-20093 + 5-FU
Arm group label:
Cohort C
Arm group label:
Cohort F
Summary:
HS-20117 is a fully-human EGFR-MET immunoglobulin G1(IgG1)-like bispecific antibody. The
purpose of study is to evaluate the safety, tolerability, efficacy, PK profile and
immunogenicity of HS-20117 in combination with other drugs in advanced solid tumors.
Detailed description:
This is a multicenter, open-label, Phase Ib clinical trial of HS-20117 combination
therapies to evaluate the safety, tolerability, efficacy, PK profile and immunogenicity
in participants with advanced solid tumors. The study includes a dose escalation part and
a dose expansion part. The dose-escalation study will be performed to evaluate the
safety, tolerability, PK profile, immunogenicity, and efficacy of HS-20117 combination
therapies in participants with advanced solid tumor. The subsequent dose-expansion study
will be performed to evaluate the efficacy of HS-20117 combination therapies in
participants with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion
mutations or EGFR classical mutations, and RAS/BRAF V600E wild type CRC.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
December 1, 2024
Completion date:
December 1, 2026
Lead sponsor:
Agency:
Hansoh BioMedical R&D Company
Agency class:
Industry
Source:
Hansoh BioMedical R&D Company
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06621563
