TerminatedPhase 1

A Study of HFB301001 in Adult Patients With Advanced Solid Tumors

Stopped: The decision to discontinue the trial was made as part of a strategic review of the Sponsor's global development portfolio. It is not related to any safety concerns, efficacy findings, recruitment difficulties, or issues with trial conduct.

United States, Spain31 participantsStarted 2022-04-20

Plain-language summary

The purpose of this study is to test the safety and tolerability of HFB301001 in patients with advanced cancers. There are two parts in this study. During the escalation part, groups of participants will receive increasing doses until a safe and tolerable doses of HFB301001 is determined. During the expansion part, participants will take the dose of study drug that was determined from the escalation part of the study and will be assigned to a group based on the type of cancer they have.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

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: * Soft tissue sarcoma: at least 1 line of therapy * Renal cell carcinoma: at least 2 lines of therapy; * Uterine carcinosarcoma: at least 1 line of therapy; * Hepatocellular carcinoma: at least 1 line of therapy * Head and neck squamous 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 * Suitable site to biopsy at pre-treatment and on-treatment * Measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and immune-RECIST (iRECIST) * 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. * For soft tissue sarcoma only: prior immune therapy or immune agonist antibodies * For uterine carcinosarcoma patients only: prior immune therapy * Therapeutic radiation therapy within the past 2 weeks * Prior exposure to agents targeting the OX40 receptor; * Active autoimmune disease requiring systemic treatment in the previous 2 years; * Systemic steroid therapy (\>10 mg/day of prednisone or equivalent) or any immune suppressive therapy. * Persisting toxicity of \>Grade 1 relating to prior anti cancer therapy with the following exceptions: * All grades of alopecia a…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with adverse events (AEs), serious AEs (SAEs), dose-limiting toxicities (DLTs), changes in laboratory values, vital signs and ECG parameters, and tolerability (dose interruptions, reductions, and dose intensity)

Timeframe: Cycle 1 Day 1 to 30 days after the last dose of HFB301001 (each cycle is 28 days)

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

Timeframe: Cycle 1 Day 1 to 30 days after the last dose of HFB301001 (each cycle is 28 days)

Trial details

NCT IDNCT05229601

SponsorHiFiBiO Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-05-30

View on ClinicalTrials.gov More Soft Tissue Sarcoma trials

A Study of HFB301001 in Adult Patients With Advanced Solid Tumors

United States, Spain31 participantsStarted 2022-04-20

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

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

Timeframe: Cycle 1 Day 1 to 30 days after the last dose of HFB301001 (each cycle is 28 days)

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

Timeframe: Cycle 1 Day 1 to 30 days after the last dose of HFB301001 (each cycle is 28 days)