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Cytokine
THOR-707 Combination Therapy for Cancer (HAMMER Trial)
Phase 1 & 2
Recruiting
Research Sponsored by Synthorx, Inc, a Sanofi company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically confirmed diagnosis of advanced and/or metastatic solid tumors with at least one tumor lesion with location accessible to safely biopsy per clinical judgment of the Investigator.
Caution: Cohorts E & F enrollment will include only patients with tumors for which anti-PD(L)1 as single agent or in combination treatments are approved.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 6 months after the end of treatment (eot)
Awards & highlights
HAMMER Trial Summary
This trial is testing the safety and effectiveness of a new cancer drug, THOR-707, either alone or in combination with other drugs. The goal is to find the best dose of THOR-707 with the least side effects. Secondary goals are to see if THOR-707 can shrink tumors, and how long any shrinkage lasts.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as inflammation in various organs which could manifest as flu-like symptoms; skin reactions; digestive issues; changes in liver function tests; fatigue; potential infusion-related reactions; and possibly others depending on individual patient responses.
HAMMER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My advanced cancer has been confirmed by lab tests and has at least one tumor that can be safely biopsied.
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My cancer type is approved for anti-PD(L)1 treatment.
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I am fully active or can carry out light work.
HAMMER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 6 months after the end of treatment (eot)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 6 months after the end of treatment (eot)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose (MTD)- Cohort G
Maximum Tolerated Dose (MTD)- Cohorts A, B, C, and D
Number of participants with treatment emergent adverse events, serious adverse events, and laboratory abnormalities - Cohorts A, B, C, D, E, F, and G
+5 moreSecondary outcome measures
Disease Control Rate (DCR) according to RECIST version 1.1
Duration of Response (DOR) according to RECIST version 1.1
Number of participants with treatment emergent adverse events, serious adverse events, laboratory abnormalities -Cohort H
+5 moreHAMMER Trial Design
8Treatment groups
Experimental Treatment
Group I: Cohort H Monotherapy QW/Q2W (Dose Expansion)Experimental Treatment1 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 Treatment1 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 Treatment2 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 Treatment2 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 Treatment2 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 Treatment2 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 Treatment1 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 Treatment1 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.
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Who is running the clinical trial?
Synthorx, Inc, a Sanofi companyLead Sponsor
Clinical Sciences & OperationsStudy DirectorSanofi
862 Previous Clinical Trials
2,019,588 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an advanced cancer and standard treatments are not suitable for me.I am not allergic to THOR-707, PEG, pegylated drugs, E. coli proteins, checkpoint inhibitors, or anti-EGFR antibodies.I haven't had cancer treatment or experimental drugs in the last 2 weeks.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.I haven't had major surgery in the last 30 days or still recovering from one.I am not currently using any experimental treatments, vaccines, or devices.My advanced cancer has been confirmed by lab tests and has at least one tumor that can be safely biopsied.I haven't had serious heart problems or surgeries in the last 6 months.I don't have another active cancer that could affect this study, except for treated skin or cervical cancer.My brain or spinal cord cancer is stable, treated, and I haven't needed specific medications for 14 days.I have KRAS mutant colon cancer and cetuximab hasn't worked for me before.My cancer type is approved for anti-PD(L)1 treatment.I have an autoimmune disease that needed treatment in the last 3 months.My heart, blood, liver, and kidneys are all functioning well.I have not used PD-1 inhibitors if I want to join Part 2 of the study.I agree to use birth control during and after the study for the required time.I am fully active or can carry out light work.I am not pregnant and have had a negative pregnancy test within the last week.I have HIV or active hepatitis C.I had a blood clot in my leg or lung in the last 3 months.Your diabetes or other immune-related endocrine conditions are not under control according to the doctor.I have metastatic melanoma and have tried at least one treatment or cannot undergo standard treatments.I do not have eye irritation or dry eyes, and I don't wear contact lenses.I have not had radiation therapy in the last 14 days.I have not received a live-virus vaccine within the last 14 days.I haven't taken IV antibiotics in the last 14 days.I had a severe reaction to previous immune therapy.My cancer can be measured by scans and I have the required number of lesions for a biopsy.I have a specific type of melanoma in my eye or related to my eye.I have not had serious bleeding in the last 2 weeks.I have had serious lung problems in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort G Monotherapy QW/Q2W (Dose Escalation)
- Group 2: Cohort F-THOR-707 Q3W with checkpoint inhibitor (Dose Expansion)
- Group 3: Cohort H Monotherapy QW/Q2W (Dose Expansion)
- Group 4: Cohort A-THOR-707 Q2W Monotherapy (Dose Escalation)
- Group 5: Cohort E-THOR-707 Q2W with checkpoint inhibitor (Dose Expansion)
- Group 6: Cohort B-THOR-707 Q3W Monotherapy (Dose Escalation)
- Group 7: Cohort D-THOR-707 Q3W with anti-EGFR antibody (Dose Escalation)
- Group 8: Cohort C-THOR-707 Q3W with checkpoint inhibitor (Dose Escalation)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the cap on participant numbers for this trial?
"The team behind this study insists on the enrollment of 300 volunteers that align with the predefined inclusion criteria. The trial is available at two sites: Investigational Site Number-1001 in San Antonio, Texas and Investigational Site Number-1003 in Nashville, Tennessee."
Answered by AI
Are there vacancies for participants in this research endeavor?
"Affirmative, clinicaltrials.gov documents affirm that this study is in the process of enrolling volunteers. The trial opened on June 20th 2019 and was last modified on July 7th 2022. It aims to include 300 individuals from seven medical centres."
Answered by AI
What objectives is this trial aiming to accomplish?
"This clinical trial, to be assessed over a one month period, is evaluating the Rate of Dose-Limiting Toxicities (DLTs). Secondary goals include measuring THOR-707 concentration in the plasma through an appropriate assay, immunophenotyping peripheral blood samples with an approved test method, and observing what percentage of participants do not experience disease progression at 6 months post treatment."
Answered by AI
Are there numerous locales operating this experiment across the North American continent?
"This medical study is currently operational at 7 locations across the country, including San Antonio, Nashville and Denver. To reduce travel costs, it's wise to pick a site near you when considering enrollment."
Answered by AI
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