GAd20-209-FSP, RP2D for Solid Tumors, Adult

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Solid Tumors, AdultGAd20-209-FSP, RP2D - Biological
Eligibility
18 - 85
All Sexes
What conditions do you have?
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Study Summary

This trial is testing a new cancer vaccine in adults with metastatic cancer. The vaccine consists of two parts, given a few weeks apart. The first part is given as an injection, and the second part is given as a smallpox-like rash. The trial will test for safety and efficacy.

Eligible Conditions
  • Solid Tumors, Adult

Treatment Effectiveness

Study Objectives

7 Primary · 4 Secondary · Reporting Duration: Through study completion, an average of 2 years

12 months
Overall Response Rate (ORR) at 12 months, in Phase IIa (Cohort C).
18 months
Overall Response Rate (ORR) at any time during the study, in Phase II (Cohort C and D).
Week 110
Clinical: Disease Control Rate (DCR), in Phase I, Cohort A and B
Clinical: Overall Response Rate (ORR), in Phase I, Cohort A and B
Week 110
Clinical: Time to Tumor Response (TTR), Phase I Main Study and Extended follow-up.
Year 2
Immunogenicity (T cell responses against vaccine FSPs) in Phase I, Cohorts A and B
Immunogenicity, in Cohorts A and B
Up to 106 weeks
Clinical: Disease control (DC)
Clinical: Objective response (OR)
Clinical: Overall Survival (OS)
Clinical:Time-to-event endpoints including: Duration of Response (DR)
Clinical:Time-to-event endpoints including: Progression-free survival (PFS)
Clinical:Time-to-event endpoints including: Time to Tumor Response (TTR)
Up to 110 weeks
Clinical: Duration of Response (DR), Phase I Main Study and Extended follow-up.
Clinical: Duration of Response (DoR), Phase I Main Study and Extended follow-up, Phase II (Cohost C and D)
Clinical: Overall Survival (OS), Phase I Main Study and Extended follow-up.
Clinical: Progression-free survival (PFS), Phase I Main Study and Extended follow-up, Phase II (Cohort C and D)
Clinical: Progression-free survival (PFS), Phase I Main Study and Extended follow-up.
Incidence of Treatment-Emergent Adverse Events, in Cohort A and B.
Incidence of Treatment-Emergent Adverse Events, in Phase I, Cohort A and B.
Safety and Tolerability, in Phase I, Cohort A and B.
Up to 18 months
Clinical: Best Overall Response (BOR), Phase II (Cohort C and D).
Clinical: Overall Survival (OS), Phase IIa (Cohort C).
Safety and tolerability (local and systemic AEs), in Phase II (Cohort C and D)
Safety and tolerability (local and systemic AEs), in Phase IIa (Cohort C)
Within 28 days
DLT assessment, in Cohort A
Toxicity (DLT assessment), in Phase I, Cohort A

Trial Safety

Trial Design

5 Treatment Groups

Cohort D - Expansion cohort Phase II
1 of 5
Cohort A - Dose-escalation
1 of 5
Cohort C - Expansion cohort Phase II
1 of 5
Cohort C - Expansion cohort Phase IIa
1 of 5
Cohort B - Expansion Cohort Phase I
1 of 5

Experimental Treatment

115 Total Participants · 5 Treatment Groups

Primary Treatment: GAd20-209-FSP, RP2D · No Placebo Group · Phase 1 & 2

Cohort D - Expansion cohort Phase IIExperimental Group · 2 Interventions: GAd20-209-FSP, RP2D, MVA-209-FSP, RP2D · Intervention Types: Biological, Biological
Cohort A - Dose-escalationExperimental Group · 2 Interventions: MVA-209-FSP low dose, GAd-209-FSP low dose · Intervention Types: Biological, Biological
Cohort C - Expansion cohort Phase IIExperimental Group · 2 Interventions: GAd20-209-FSP, RP2D, MVA-209-FSP, RP2D · Intervention Types: Biological, Biological
Cohort C - Expansion cohort Phase IIaExperimental Group · 2 Interventions: GAd20-209-FSP, RP2D, MVA-209-FSP, RP2D · Intervention Types: Biological, Biological
Cohort B - Expansion Cohort Phase IExperimental Group · 2 Interventions: GAd-209-FSP high dose, MVA-209-FSP high dose · Intervention Types: Biological, Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 2 years

Who is running the clinical trial?

Nouscom SRLLead Sponsor
1 Previous Clinical Trials
34 Total Patients Enrolled
Patricia Delaite, MDStudy DirectorNouscom SRL

Eligibility Criteria

Age 18 - 85 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have resolution of toxic effect(s) of the most recent prior chemotherapy to Grade 1 or less (except alopecia)
You have adequate hematological and blood chemistry values as indicated in Table 1.\n
You must agree to have a first biopsy at baseline from a lesion that can be biopsied with an acceptable clinical risk (as judged by the Investigator in discussion with the interventional radiologist or endoscopist).
You must agree to have a second on-treatment biopsy that will be taken only if not representing an unacceptable clinical risk and/or if technically feasible as judged by the Investigator in discussion with the interventional radiologist or endoscopist.
Subjects are eligible to Cohort A based on previous diagnosis for MSI status
Subjects with unresectable or metastatic, microsatellite instability high (MSI-H) or mismatch repair deficient CRC, gastric or G-E junction tumors who have progressed following prior treatment (2nd or further line of treatment) or who are ineligible for chemotherapy; or for whom a clinical trial of an investigational agent plus pembrolizumab is considered appropriate by the Investigator (1st line of treatment).