THOR-707 Combination Therapy for Cancer

(HAMMER Trial)

Recruiting at 23 trial locations

Overseen By Trial Transparency email recommended Toll Free Number for US and Canada

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Synthorx, Inc, a Sanofi company

Must not be taking: Systemic steroids, Immunosuppressive agents

Disqualifiers: Autoimmune disease, CNS disease, Uncontrolled diabetes, Severe cardiac condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

250 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called THOR-707 to see if it is safe and effective for cancer patients. The drug aims to help the immune system fight cancer. The study will check how well the drug works alone and with other treatments.

Research Team

Clinical Sciences & Operations

Principal Investigator

Sanofi

Eligibility Criteria

Adults with advanced or metastatic solid tumors who have tried standard treatments without success, are intolerant to them, or have no other effective options available. Participants should not have received certain cancer therapies recently and must be free of specific health conditions like uncontrolled diabetes or active infections. They need functioning major organs, measurable disease per RECIST v1.1 criteria, a life expectancy over 12 weeks, and an ECOG status of 0-1.

Inclusion Criteria

I have an advanced cancer and standard treatments are not suitable for me.

I agree not to donate or bank sperm during and for 3 days after treatment.

I have had cancer treatment before, but any side effects are now under control.

Exclusion Criteria

I am not allergic to THOR-707, PEG, pegylated drugs, E. coli proteins, checkpoint inhibitors, or anti-EGFR antibodies.

History of allogenic or solid organ transplant.

I haven't had cancer treatment or experimental drugs in the last 2 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive THOR-707 as monotherapy or in combination with other agents, with dose escalation and expansion phases

6 weeks

Weekly visits for dose administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 24 months

Treatment Details

Interventions

• anti-EGFR antibody
• Checkpoint inhibitor
• THOR-707

Trial Overview The trial is testing THOR-707 alone and in combination with an anti-EGFR antibody or checkpoint inhibitor for safety and maximum tolerated dose (MTD). It also aims to observe the preliminary effectiveness by measuring tumor response rates, time to response, duration of response, progression-free survival (PFS), overall survival (OS), and disease control rate.

Participant Groups

Group I: Cohort H Monotherapy QW/Q2W (Dose Expansion) Experimental Treatment 1 Intervention

Subjects with late-line metastatic melanoma will receive THOR707 monotherapy at RP2D for Cohort G. Cycle 1 will consist of THOR-707 QW for 6 weeks; Cycle 2 and beyond will consist of THOR-707 Q2W.

Group II: Cohort G Monotherapy QW/Q2W (Dose Escalation) Experimental Treatment 1 Intervention

Subjects with advanced or metastatic solid tumors will receive THOR707 monotherapy QW for 6 weeks (induction period), and then every Q2W (maintenance period), which is referred as QW/Q2W thereafter, until unacceptable toxicity, disease progression, or withdrawal of consent.

Group III: Cohort F-THOR-707 Q3W with checkpoint inhibitor (Dose Expansion) Experimental Treatment 2 Interventions

Subjects with advanced or metastatic solid tumors will receive THOR-707 Q3W at recommended Phase 2 dose (RP2D) with a checkpoint inhibitor via IV administration Q6W will consist of one 9-week cycle of THOR monotherapy on Cycle 1 Day 1 followed by THOR-707 Q3W + checkpoint inhibitor at Cycle 1 Day 22. Subsequently treatment will consist of repeated 6-weeks cycles with combination therapy.

Group IV: Cohort E-THOR-707 Q2W with checkpoint inhibitor (Dose Expansion) Experimental Treatment 2 Interventions

Subjects with advanced or metastatic solid tumors will receiveTHOR-707 Q2W at recommended Phase 2 dose (RP2D) with a checkpoint inhibitor via IV administration Q6W; it will consist of one 8-week cycle of THOR-707 monotherapy on Cycle 1 Day 1 followed by THOR-707 Q2W + checkpoint inhibitor Q6W starting at Cycle 1 Day 15. Subsequently treatment will consist of repeated 6-week cycles with combination therapy.

Group V: Cohort D-THOR-707 Q3W with anti-EGFR antibody (Dose Escalation) Experimental Treatment 2 Interventions

Subjects with advanced or metastatic solid tumors will receive THOR-707 Q3W in sequential ascending doses in combination with an anti-EGFR antibody weekly dosing (QW) via IV administration until unacceptable toxicity, disease progression, or withdrawal of consent.

Group VI: Cohort C-THOR-707 Q3W with checkpoint inhibitor (Dose Escalation) Experimental Treatment 2 Interventions

Subjects with advanced or metastatic solid tumors will receive THOR-707 Q3W in sequential ascending doses in combination with a checkpoint inhibitor Q3W or every 6 weeks (Q6W) via IV administration until unacceptable toxicity, disease progression, or withdrawal of consent.

Group VII: Cohort B-THOR-707 Q3W Monotherapy (Dose Escalation) Experimental Treatment 1 Intervention

Subjects with advanced or metastatic solid tumors will receive THOR-707 in sequential ascending doses as a monotherapy via IV administration every 3 weeks (Q3W) until unacceptable toxicity, disease progression, or withdrawal of consent.

Group VIII: Cohort A-THOR-707 Q2W Monotherapy (Dose Escalation) Experimental Treatment 1 Intervention

Subjects with advanced or metastatic solid tumors will receive THOR-707 in sequential ascending doses as a monotherapy via intravenous (IV) administration every 2 weeks (Q2W) until unacceptable toxicity, disease progression, or withdrawal of consent.

Who Is Running the Clinical Trial?

Synthorx, Inc, a Sanofi company

Lead Sponsor

Trials

1

Recruited

250+