HFB301001 for Advanced Cancers

Recruiting at 9 trial locations

Overseen By Jesse Cotugno, Clinical Trial Manager

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: HiFiBiO Therapeutics

Must not be taking: Steroids, Immunosuppressants

Disqualifiers: Autoimmune, Diabetes, Coagulopathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Variable (depends on response)

84 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Adults with advanced solid tumors like sarcoma, melanoma, and various carcinomas who've had at least one line of therapy for their cancer can join. They need measurable disease, good performance status, and a tumor that can be biopsied. Excluded are those on high-dose steroids or immune suppressants, unstable health conditions, recent major surgery or lung issues from drugs.

Inclusion Criteria

Melanoma:

Previously received the following lines of systemic therapy for the advanced/metastatic disease:

BRAF V600E wild type: must have received at least 1 line of therapy

Exclusion Criteria

Systemic steroid therapy (>10 mg/day of prednisone or equivalent) or any immune suppressive therapy

Severe or unstable medical condition, including uncontrolled diabetes, coagulopathy, or unstable psychiatric condition

Major surgery within 2 weeks of the first dose of study drug

Timeline

Screening

Participants are screened for eligibility to participate in the trial

up to 4 weeks

Treatment

Participants receive HFB301001 via intravenous infusions on the first day of each 28-day cycle. The number of cycles depends on the disease response.

Variable (depends on response)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 visit

Treatment Details

Interventions

• HFB301001

Trial Overview HFB301001's safety is being tested in two parts: first to find a safe dose by gradually increasing it among groups; then using this dose in more people based on their cancer type. The goal is to see how well patients tolerate the drug and its effects on different cancers.

Participant Groups

Group I: HFB301001 Experimental Treatment 1 Intervention

Participants will receive HFB301001 via intravenous infusions

Who Is Running the Clinical Trial?

HiFiBiO Therapeutics

Lead Sponsor

Trials

5

Recruited

380+