CyPep-1 + Pembrolizumab for Advanced Cancers (Catalyst Trial)

Recruiting in Palo Alto (17 mi)

+24 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Cytovation AS

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial tests a new treatment that injects a special protein and an immune-boosting drug into tumors. It targets patients with advanced or hard-to-treat cancers. The treatment helps the immune system recognize and attack cancer cells.

Eligibility Criteria

Adults with advanced or metastatic cancers such as head and neck, breast, melanoma, or squamous cell carcinoma. Participants must have a measurable tumor for injection, be able to provide biopsy tissue, have an ECOG performance status of 0 or 1 (fully active or restricted in physically strenuous activity but ambulatory), and adequate organ function. Pregnant women, those with recent cancer treatments or surgeries, certain infections like HIV/SARS-CoV-2/Hepatitis B/C, autoimmune diseases requiring immunosuppression within the last two years are excluded.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.

I am 18 years old or older.

I have a tumor that can be reached for injection and is not an open sore.

Exclusion Criteria

I have had a transplant of tissue, organ, stem cell, or bone marrow.

I have a heart condition related to abnormal heart rhythms.

I am allergic to ingredients in CyPep-1 or pembrolizumab.

My cancer has spread to 4 or more places, including where it started.

I am not under legal protection, vulnerable, or unable to give informed consent.

I have or had lung inflammation not caused by infection, treated with steroids.

I have a history of Hepatitis B or active Hepatitis C.

I have brain metastases that are causing symptoms or getting worse.

My skin cancer cannot be felt by touch.

I haven't had cancer treatment in the last 4 weeks (2 weeks for palliative radiotherapy).

I have not had a live vaccine within 30 days before starting CyPep-1.

I am currently being treated for an infection.

I have another cancer that is growing or needs treatment, except for early skin cancer or carcinoma in situ.

I am HIV positive.

I haven't needed immunosuppressive therapy for an autoimmune disease in the last 2 years.

I have not had major surgery in the last 2 weeks.

I will need cancer treatment during the study, but not just local pain relief radiation.

Participant Groups

The trial is testing CyPep-1 injected into tumors combined with pembrolizumab (Keytruda) infusion. It aims to evaluate how safe and effective this combination is against various cancers by observing its impact on both treated and untreated tumor sites as well as overall immune response.

3Treatment groups

Experimental Treatment

Group I: Arm C: advanced or metastatic TNBCExperimental Treatment2 Interventions

The safety and tolerability of CyPep-1 in combination with pembrolizumab will be evaluated in a cohort of 30 subjects in total with advanced or metastatic TNBC. CyPep-1 will be administered every 2 weeks (Q2W) and pembrolizumab will be administered following a Q6W schedule as per standard of care (SoC).

Group II: Arm B: advanced or metastatic melanomaExperimental Treatment2 Interventions

The safety and tolerability of CyPep-1 in combination with pembrolizumab will be evaluated in a cohort of 30 subjects in total with advanced or metastatic melanoma. CyPep-1 will be administered every 2 weeks (Q2W) and pembrolizumab will be administered following a Q6W schedule as per standard of care (SoC).

Group III: Arm A: advanced or metastatic HNSCCExperimental Treatment2 Interventions

The safety and tolerability of CyPep-1 in combination with pembrolizumab will be evaluated in a cohort of 30 subjects in total with advanced or metastatic HNSCC. CyPep-1 will be administered every 2 weeks (Q2W) and pembrolizumab will be administered following a Q6W schedule as per standard of care (SoC).