Active — Not RecruitingPhase 1

A Study of HFB200301 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors

United States72 participantsStarted 2022-03-10

Plain-language summary

The purpose of this study is to test the safety and tolerability of HFB200301 as a single agent and in combination with tislelizumab in patients with advanced cancers. There are two parts in this study. During the escalation part, groups of participants will receive increasing doses of HFB200301 as a monotherapy or in combination with tislelizumab until a safe and tolerable dose of HFB200301 as a single agent or combination therapy is determined. During the expansion part, participants will take the dose of HFB200301 as a monotherapy or in combination with tislelizumab that was determined from the escalation part of the study and will be assigned to a group based on the type of cancer the participants have.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Previously received the following lines of systemic therapy for the advanced/metastatic disease: * Gastric cancer: at least 2 lines of therapy * Renal cell carcinoma: at least 2 lines of therapy * Melanoma: * BRAF V600E mutant: must have received at least 2 lines of therapy * BRAF V600E wild type: must have received at least 1 line of therapy * Sarcoma: at least 1 line of therapy * Testicular germ cell tumor: at least 2 lines of therapy * Cervical cancer: at least 2 lines of therapy * Mesothelioma: at least 2 lines of therapy * Non-small cell lung cancer: at least 2 lines of therapy * Head and neck squamous cell carcinoma: at least 2 lines of therapy * Suitable site to biopsy at pre-treatment and on-treatment * Measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or modified RECIST (mRECIST) for mesothelioma * Eastern Cooperative Oncology Group performance status of 0 or 1 Exclusion Criteria: * Systemic anti-cancer therapy within 2 weeks prior to start of study drug or within 4 weeks for immune-oncologic therapy * For soft tissue sarcoma and testicular germ cell tumor patients only: prior immune therapy * Therapeutic radiation therapy within the past 2 weeks * Prior exposure to agents targeting the Tumor Necrosis Factor Receptor type 2 (TNFR2) receptor * Active autoimmune disease requiring systemic treatment in the previous 2 years * Systemic steroid therapy (\>10 mg/day of prednison…

What they're measuring

Number of participants with adverse events (AEs), serious AEs (SAEs), dose-limiting toxicities (DLTs), and tolerability (dose interruptions, reductions, and dose intensity)

Timeframe: assessed up to 3 years

To determine a Recommended Phase 2 Dose (RP2D) during Dose Expansion

Timeframe: assessed up to 3 years

Trial details

NCT IDNCT05238883

SponsorHiFiBiO Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12

View on ClinicalTrials.gov More Gastric Cancer trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of participants with adverse events (AEs), serious AEs (SAEs), dose-limiting toxicities (DLTs), and tolerability (dose interruptions, reductions, and dose intensity)

Timeframe: assessed up to 3 years

To determine a Recommended Phase 2 Dose (RP2D) during Dose Expansion

Timeframe: assessed up to 3 years