VAXINIA + Pembrolizumab for Cancer
(MAST Trial)

Recruiting in Palo Alto (17 mi)

+12 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Imugene Limited

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing a new virus-based treatment alone or with an immune-boosting drug in patients with advanced cancers who haven't responded to other treatments. The virus kills cancer cells, and the drug helps the immune system fight the cancer. These viruses are designed to target and kill tumor cells while leaving the normal cells unharmed, and they have shown promising results in earlier studies.

Research Team

Eligibility Criteria

Adults with metastatic or advanced solid tumors who have tried at least two treatments can join this trial. They must be over 18, able to perform daily activities (ECOG 0-2), and have good kidney, liver, and blood function. People with active autoimmune diseases, poor heart or lung function, brain metastases that aren't controlled, recent radiotherapy or those on high-dose steroids or other immune-suppressing drugs cannot participate.

Inclusion Criteria

I am 18 years old or older.

At least one measurable lesion

Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

See 6 more

Exclusion Criteria

I have not had radiotherapy in the last 2 weeks.

Active autoimmune disease

I have serious heart conditions, such as severe heart failure or uncontrolled high blood pressure.

See 5 more

Treatment Details

Interventions

CF33-hNIS (Virus Therapy)
Pembrolizumab (Checkpoint Inhibitor)

Trial OverviewThe study is testing CF33-hNIS (an oncolytic virus) given directly into the tumor or through the vein as a single agent or combined with Pembrolizumab. It's an early-phase trial to see how safe these treatments are and what doses might work best for people with hard-to-treat cancers.

Participant Groups

4Treatment groups

Experimental Treatment

Group I: CF33-hNIS IV Administration in Combination with PembrolizumabExperimental Treatment2 Interventions

Group II: CF33-hNIS IV Administration MonotherapyExperimental Treatment1 Intervention

Group III: CF33-hNIS IT Administration in Combination with PembrolizumabExperimental Treatment2 Interventions

Group IV: CF33-hNIS IT Administration MonotherapyExperimental Treatment1 Intervention