THOR-707 Combination Therapy for Cancer
(HAMMER Trial)
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive THOR-707 as monotherapy or in combination with other agents, with dose escalation and expansion phases
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
8
Treatment groups
Experimental Treatment
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.
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.
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.
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.
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.
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Synthorx, Inc, a Sanofi company
Lead Sponsor
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 ...
2.
aacrjournals.org
aacrjournals.org/cancerres/article/81/13_Supplement/LB041/669872/Abstract-LB041-THOR-707-SAR444245-a-novel-notAbstract 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: NCT04009681
A 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)
6.
sanofistudies.com
sanofistudies.com/cwout/CW-V9DEXS//us/en/listing/286455/a-study-evaluating-safety/A Study Evaluating Safety and Therapeutic Activity of
Who 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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