Clinical trial NCT05824663: A Study Evaluating the Safety, Tolerance and Anti-tumor Activity of HBM1020 in Subjects With Advanced Solid Tumors
Official title: A Phase 1 Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of HBM1020 in Subjects With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Advanced Solid Tumor
Keywords: Advanced Solid Tumors
Lead sponsor: Harbour BioMed US, Inc.
Sponsor class: INDUSTRY
First posted: 2023-04-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study to evaluate the safety and tolerability of the study drug HBM1020 which contains two parts. Part 1 will enroll solid tumor participants and Part 2 will enroll renal cell carcinoma (RCC) and colorectal adenocarcinoma (CRC).

Detailed description: This is a study to evaluate the safety and tolerability of the study drug HBM1020, and to determine the maximum tolerated dose and/or recommended Phase 2 study dose of HBM1020. The study will also look at the anti-tumor activity of HBM1020.The study consists of 2 parts. In Part 1, patients are enrolled into different cohort doses in order to identify the appropriate recommended phase 2 dose (RP2D) or maximum tolerated dose (MTD). In Part 2, participants with metastatic/unresectable RCC, CRC will receive the MTD and/or RP2D established in Part 1 of the study. In Part 1 and Part 2, participants will be administered treatment every 3 weeks.

Eligibility criteria: Inclusion Criteria:

1. Willingness to sign a written informed consent document.
2. Male or female subject aged ≥18 years old at the time of screening.
3. Histologically or cytologically confirmed advanced solid tumors or recurrent and progressed since last antitumor therapy for which no alternative, curative standard therapy exists.
4. Adequate organ and bone marrow function.

Exclusion Criteria:

1. Prior used anti-B7H7 monoclonal antibodies (mAb) or anti-KIR3DL3 monoclonal antibodies (mAb).
2. Any systemic anti-cancer therapy within 4 weeks prior to first dose of investigational medicinal product (IMP), or immunosuppressive medications within 2 weeks before the first dose of investigational medicinal product (IMP).
3. Not yet recovered from surgery or (immune-related) toxicity related with previous treatment.
4. With clinically significant congenital or acquired cardiovascular diseases.
5. With severe or uncontrolled systemic diseases, including uncontrolled hypertension, uncontrolled diabetes mellitus, active bleeding diatheses, or active infection including hepatitis B, hepatitis C, autoimmune disease and human immunodeficiency virus.
6. Presence of other active invasive cancers other than the one treated in this study within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin, or in situ carcinoma of uterine cervix, or other local tumors considered cured by local treatment.
7. Major surgery (excluding placement of vascular access) within 4 weeks of first dose of study drug.
8. Previously untreated brain metastases.
9. Pregnant or breastfeeding women.

Primary outcomes:
measure: Proportion of subjects with dose-limiting toxicity (DLT)
timeFrame: From Day 1 until disease progression or Day 21, whichever comes first.
Secondary outcomes:
measure: Adverse events (AEs)
timeFrame: From the date of informed consent until safety follow-up Day 90.
measure: Objective response rate (ORR)
timeFrame: Up to 2 years or until progressive disease, unacceptable toxicity, subject withdraw consent or investigator's decision, whichever occurs first.
measure: Duration of response
timeFrame: Up to 2 years or until progressive disease, unacceptable toxicity, subject withdraw consent or investigator's decision, whichever occurs first.
measure: Disease control rate
timeFrame: Up to 2 years or until progressive disease, unacceptable toxicity, subject withdraw consent or investigator's decision, whichever occurs first.
measure: Duration of disease control
timeFrame: Up to 2 years or until progressive disease, unacceptable toxicity, subject withdraw consent or investigator's decision, whichever occurs first
measure: Tumor shrinkage (The percentage of patients with tumor shrinkage)
timeFrame: Up to 2 years or until progressive disease, unacceptable toxicity, subject withdraw consent or investigator's decision, whichever occurs first.
measure: Maximum serum concentration (Cmax)
timeFrame: Up to 90 days after end of treatment.
measure: Time to reach maximum serum concentration (Tmax)
timeFrame: Up to 90 days after end of treatment.
measure: Area under the serum concentration versus time curve from time zero to the dosing interval tau (AUC0-tau)
timeFrame: Up to 90 days after end of treatment.
Other outcomes:
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