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Checkpoint Inhibitor

TBio-6517 + Pembrolizumab for Solid Tumors (RAPTOR Trial)

Phase 1 & 2

Waitlist Available

Research Sponsored by Turnstone Biologics, Corp.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug, TBio-6517, alone and with another medication in patients with certain solid tumors. It aims to find the best dose and see if the combination helps the immune system fight cancer better.

Eligible Conditions

Mesothelioma
Skin Cancer
Kidney Cancer
Oropharyngeal Cancer
Solid Tumors
Colorectal Cancer
Oropharyngeal Carcinoma
Cervical Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events when TBio-6517 administered by direct injection into tumor(s) alone at each dose level

Incidence of adverse events when TBio-6517 administered by direct injection into tumor(s) when combined with pembrolizumab

Maximum tolerated dose (MTD) or Maximum feasible dose (MFD) and determination of the recommended Phase 2 dose (RP2D) of TBio-6517 alone and in combination with pembrolizumab.

+2 more

Secondary study objectives

Median Disease Control Rate (DCR)

Median Duration of Response (DoR)

Median overall survival (OS)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

8Treatment groups

Experimental Treatment

Group I: TBio-6517 and Pembrolizumab in cutaneous squamous cell carcinoma of the skinExperimental Treatment2 Interventions

Doses of TBio-6517 will be administered by direct injection into tumor(s) x 4 in combination with pembrolizumab beginning at Day 8 given every 3 weeks for up to 24 months in patients with cSCC. Booster injections of TBio-6517 are permitted for up to 24 months.

Group II: TBio-6517 and Pembrolizumab in cutaneous melanomaExperimental Treatment2 Interventions

Doses of TBio-6517 will be administered by direct injection into tumor(s) x 4 in combination with pembrolizumab beginning at Day 9 given every 3 weeks for up to 24 months in patients with malignant melanoma of the skin. Booster injections of TBio-6517 are permitted for up to 24 months.

Group III: TBio-6517 and Pembrolizumab in MSS-CRCExperimental Treatment2 Interventions

Doses of TBio-6517 will be administered by direct injection into tumor(s) x 4 in combination with pembrolizumab beginning at Day 9 given every 3 weeks for up to 24 months in patients with microsatellite stable colorectal carcinoma (MSS-CRC). Booster injections of TBio-6517 are permitted for up to 24 months.

Group IV: TBio-6517 and Pembrolizumab in HPV positive head and neck cancerExperimental Treatment2 Interventions

Doses of TBio-6517 will be administered by direct injection into tumor(s) x 4 in combination with pembrolizumab beginning at Day 9 given every 3 weeks for up to 24 months in patients with HPV associated oropharyngeal cancer. Booster injections of TBio-6517 are permitted for up to 24 months.

Group V: Arm D: TBio-6517 intravenous and PembrolizumabExperimental Treatment2 Interventions

Dose escalation of TBio-6517 administered in combination with pembrolizumab. Dose escalation of TBio-6517 alone administered by intravenous infusion x 4. Booster infusions of TBio-6517 are permitted for up to 24 months. Pembrolizumab will be administered beginning at Day 9 via intravenous (IV) infusion every 3 weeks for up to 24 months.

Group VI: Arm C: TBio-6517 intravenousExperimental Treatment1 Intervention

Dose escalation of TBio-6517 alone administered by intravenous infusion x 4. Booster infusions of TBio-6517 are permitted for up to 24 months.

Group VII: Arm B: TBio-6517 and PembrolizumabExperimental Treatment2 Interventions

Dose escalation of TBio-6517 administered in combination with pembrolizumab. TBio-6517 will be directly injected into tumor(s) x 4. Booster injections of TBio-6517 are permitted for up to 24 months. Pembrolizumab will be administered beginning at Day 9 via intravenous (IV) infusion every 3 weeks for up to 24 months.

Group VIII: Arm A: TBio-6517 aloneExperimental Treatment1 Intervention

Dose escalation of TBio-6517 alone administered by direct injection into tumor(s) x 4. Booster injections of TBio-6517 are permitted for up to 24 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~2810

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