TerminatedPhase 1

Study of TBio-6517 Given Alone or in Combination With Pembrolizumab in Solid Tumors

Stopped: Sponsor decision

United States27 participantsStarted 2020-06-02

Plain-language summary

To determine the recommended Phase 2 dose (RP2D) of TBio-6517 when administered by direct injection into tumor(s) or intravenously and when combined with pembrolizumab in patients with solid tumors (RIVAL-01).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Advanced (unresectable) or metastatic, intra or extra hepatic adenocarcinoma originating from the bile duct, CCA (Cohort 1) having progressed on at least 1 line of systemic therapy (including targeted therapy if eligible)
✓. Locally advanced or metastatic cutaneous melanoma (Cohort 2) that has failed anti-PD-1 or anti-PDL1 therapy (+/- anti-CTLA-4 therapy) and if BRAF+, having failed a BRAF/ +/-MEK inhibitor
✓. Locally advanced or metastatic cSCC (Cohort 3) that has not received systemic therapy (e.g., local resection or local topical therapy is permitted).
✓. Locally advanced or metastatic MSS-CRC (Cohort 4) patients that have progressed on at least 2 prior lines of systemic therapy which should include irinotecan and oxaliplatin +/- targeted therapy if warranted.

What they're measuring

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

Timeframe: 25 months

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

Timeframe: 25 months

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.

Timeframe: 4 weeks

Percentage of overall response rate (ORR) by RECIST 1.1 at the RP2D

Timeframe: 25 months

Percentage of overall response rate (ORR) by immunotherapy RECIST (iRECIST) at the RP2D

Timeframe: 25 months

Trial details

NCT IDNCT04301011

SponsorTurnstone Biologics, Corp.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-01-23

View on ClinicalTrials.gov More Solid Tumor trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Advanced (unresectable) or metastatic, intra or extra hepatic adenocarcinoma originating from the bile duct, CCA (Cohort 1) having progressed on at least 1 line of systemic therapy (including targeted therapy if eligible)
✓. Locally advanced or metastatic cutaneous melanoma (Cohort 2) that has failed anti-PD-1 or anti-PDL1 therapy (+/- anti-CTLA-4 therapy) and if BRAF+, having failed a BRAF/ +/-MEK inhibitor
✓. Locally advanced or metastatic cSCC (Cohort 3) that has not received systemic therapy (e.g., local resection or local topical therapy is permitted).
✓. Locally advanced or metastatic MSS-CRC (Cohort 4) patients that have progressed on at least 2 prior lines of systemic therapy which should include irinotecan and oxaliplatin +/- targeted therapy if warranted.

What they're measuring

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

Timeframe: 25 months

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

Timeframe: 25 months

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.

Timeframe: 4 weeks

Percentage of overall response rate (ORR) by RECIST 1.1 at the RP2D

Timeframe: 25 months

Percentage of overall response rate (ORR) by immunotherapy RECIST (iRECIST) at the RP2D

Timeframe: 25 months