THOR-707 Combination Therapy for Cancer

(HAMMER Trial)

Not currently recruiting at 23 trial locations
TT
Overseen ByTrial Transparency email recommended Toll Free Number for US and Canada
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new cancer treatment called THOR-707, both alone and with other therapies, to evaluate its safety and effectiveness against tumors. Researchers seek to determine the best dose patients can tolerate and assess its potential to shrink tumors. The trial includes different groups: some receive THOR-707 alone, while others receive it with additional treatments, such as checkpoint inhibitors, which help the immune system attack cancer. This trial targets individuals with advanced or metastatic solid tumors who have tried other treatments without success or have limited options. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering patients a chance to be among the first to receive this new therapy.

Do I have to stop taking my current medications for the THOR-707 trial?

The trial protocol does not clearly specify if you need to stop taking your current medications. However, you cannot have had certain treatments like radiotherapy or systemic anti-cancer therapy shortly before starting the trial. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that THOR-707 is under study for its safety in humans, both alone and with other treatments. Early studies suggest that THOR-707 is generally well-tolerated, though it can have side effects like many treatments.

Previous studies found some side effects when used alone, but they were mostly manageable, meaning they were not severe for most people.

When combined with a checkpoint inhibitor (a drug that helps the immune system fight cancer), safety studies found a similar pattern. Side effects occurred but were usually mild and treatable.

In combination with an anti-EGFR antibody (a drug that blocks cancer growth signals), THOR-707 also showed a tolerable safety profile. Again, side effects were present but mostly manageable.

Since this trial is in its early stages, it continues to collect safety information. Early trials often focus on understanding side effects and finding the best dose to reduce them. While the trial is ongoing, data so far indicates that THOR-707 is relatively safe, but participants should be aware of potential side effects.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about THOR-707 because it offers a unique approach to treating advanced or metastatic cancers. Unlike traditional treatments like chemotherapy, which indiscriminately attack both cancerous and healthy cells, THOR-707 is a pegylated cytokine that selectively stimulates the immune system to target and destroy cancer cells. By enhancing the body's own immune response, THOR-707 aims to achieve similar or improved effectiveness with potentially fewer side effects. Additionally, when combined with checkpoint inhibitors or anti-EGFR antibodies, THOR-707 could amplify the immune response further, offering a promising new strategy for challenging cancers like metastatic melanoma and solid tumors.

What evidence suggests that this trial's treatments could be effective for cancer?

Research shows that THOR-707 may help treat cancer. Studies have found that THOR-707 boosts the immune system by increasing CD8+ T cells, which play a crucial role in fighting tumors. In this trial, participants will receive THOR-707 either as a monotherapy or combined with other treatments. Some participants will receive THOR-707 with checkpoint inhibitors, which studies suggest may enhance its effectiveness. Early studies also indicate that THOR-707 can improve cancer treatment without causing the severe side effects seen with some older drugs. Overall, these findings suggest THOR-707 could be a promising treatment option for people with advanced cancers.23678

Who Is on the Research Team?

CS

Clinical Sciences & Operations

Principal Investigator

Sanofi

Are You a Good Fit for This Trial?

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.
See 12 more

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.
See 22 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
8Treatment groups
Experimental Treatment
Group I: Cohort H Monotherapy QW/Q2W (Dose Expansion)Experimental Treatment1 Intervention
Group II: Cohort G Monotherapy QW/Q2W (Dose Escalation)Experimental Treatment1 Intervention
Group III: Cohort F-THOR-707 Q3W with checkpoint inhibitor (Dose Expansion)Experimental Treatment2 Interventions
Group IV: Cohort E-THOR-707 Q2W with checkpoint inhibitor (Dose Expansion)Experimental Treatment2 Interventions
Group V: Cohort D-THOR-707 Q3W with anti-EGFR antibody (Dose Escalation)Experimental Treatment2 Interventions
Group VI: Cohort C-THOR-707 Q3W with checkpoint inhibitor (Dose Escalation)Experimental Treatment2 Interventions
Group VII: Cohort B-THOR-707 Q3W Monotherapy (Dose Escalation)Experimental Treatment1 Intervention
Group VIII: Cohort A-THOR-707 Q2W Monotherapy (Dose Escalation)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Synthorx, Inc, a Sanofi company

Lead Sponsor

Trials
1
Recruited
250+

Citations

481 Phase 1/2 study of THOR-707 (SAR444245), a ...Conclusions SAR444245 was well tolerated and demonstrated antitumor activity in heavily pretreated patients, including prior checkpoint ...
Abstract LB041: THOR-707 (SAR444245), a novel not-alpha ...In animal models, THOR-707 improved the anti-tumor benefits of aldesleukin, but without its severe side effects, both as single agent and ...
Clinical Trial: NCT04009681A Study Evaluating Safety and Therapeutic Activity of THOR-707 in Adult Subjects With Advanced or Metastatic Solid Tumors. NCT04009681 ...
THOR-707: Using synthetic biology to reprogram ...Efficacy in tumor models was durable, suggesting activation of CD8+ memory T cell populations. Conclusions: THOR-707 is a reprogrammed, site-directed, singly- ...
A Study Evaluating Safety and Therapeutic Activity of ...A Study Evaluating Safety and Therapeutic Activity of THOR-707 in Adult Subjects With Advanced or Metastatic Solid Tumors (THOR-707-101)
A Study Evaluating Safety and Therapeutic Activity ofWho can participate: Participants must have advanced or metastatic solid tumors and a life expectancy of at least 12 weeks. They should have measurable disease ...
A Study Evaluating Safety and Therapeutic Activity ...A first-in-human trial evaluating the safety, therapeutic activity and maximum tolerable dose of THOR-707 (SAR444245), a highly differentiated not-alpha ...
Interim late-breaking clinical data validate not-alpha profile ...Interim data from a first-in-human trial evaluating the safety, therapeutic activity and maximum tolerable dose of THOR-707 (SAR444245).
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