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Immune Checkpoint Inhibitors

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.

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 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 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 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 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 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 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.

Pharmaceutical form: solution for intravenous (IV) administration; Route of administration: IV administration

THOR-707

Pharmaceutical form: solution for IV administration; Route of administration: IV administration

Checkpoint inhibitor

anti-EGFR antibody

Trial Transparency email recommended Toll Free Number for US and Canada

Clinical Sciences & Operations

Primary Objectives:

* Evaluate the safety and tolerability of THOR-707 as a single agent and as a combination therapy (identify Dose Limiting Toxcitiy (DLTs) in Cohorts A, B, C, D, and G, and adverse events (AEs)/serious adverse event (SAE) profile in Cohorts A, B, C, D, E, F, and G)
* Define the Maximium Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RP2D) of THOR-707 as a single agent and as a combination therapy (Cohorts A, B, C, D, and G)
* Evaluate preliminary anti-tumor activity of THOR-707 as a single agent by determination of the objective response rate (ORR) defined according to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (Cohort H only)

Secondary Objectives:

* Evaluate preliminary anti-tumor activity of THOR-707 as a single agent and as a combination therapy by determination of the objective response rate (ORR) defined according to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (Cohorts A, B, C, D, E, F, and G)
* Determine time to response (TTR), duration of response (DOR), progression-free survival (PFS), overall survival (OS), and disease control rate (DCR) of THOR-707 as a single agent and as a combination therapy
* Evaluate the safety and tolerability of THOR-707 monotherapy QW/Q2W (AE/serious adverse event \[SAE\] profile) (Cohort H only).

The study duration per participant is approximately 24 months (inclusive of follow-up). Cohorts A, B, C, and D have been completed.

A Study Evaluating Safety and Therapeutic Activity of THOR-707 in Adult Subjects With Advanced or Metastatic Solid Tumors (THOR-707-101)

An Open-Label, Multicenter Phase 1/2 Dose Escalation and Expansion Study of THOR-707 as a Single Agent and as a Combination Therapy in Adult Subjects With Advanced or Metastatic Solid Tumors

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org.

Safety will be assessed by monitoring adverse events, clinical laboratory evaluations, vital signs, and ECG parameters.

ORR, defined as the proportion of subjects with confirmed complete response (CR) or partial response (PR); a confirmed response is a response that persists on repeat-imaging ≥4 weeks after initial documentation of response.

Defined as the proportion of subjects with confirmed complete response (CR) or partial response (PR); a confirmed response is a response that persists on repeat-imaging ≥4 weeks after initial documentation of response.

Defined as time from date of first objective response (either CR or PR) to first documentation of radiographic disease progression or death due to any cause, whichever occurs first.

Defined as the time from first dose of THOR-707 to first documentation of radiographic disease progression or death due to any cause, whichever occurs first.

Defined as the time from first dose of THOR-707 to the date of death due to any cause.

Defined as the time from first dose of THOR-707 to first documentation of objective response (either CR or PR).

Defined as the proportion of subjects who have achieved CR, PR, or stable disease (duration of stable disease should be ≥3 months).

The End of Treatment (EOT) visit is performed within 30 days after a subject discontinues from study drug administration and prior to the subject beginning any subsequent anti-cancer therapy.

Synthorx, Inc, a Sanofi company

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Carcinoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Oropharyngeal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Cemiplimab

Participants will receive SAR444245 and Cemiplimab by vein on Day 1 of Cycles 1 and 2. Each drug's infusion should take about 30 minutes.

SAR444245

Renata Ferrarotto, MD

To learn if SAR444245 given in combination with cemiplimab can help to kill cancer cells in patients with HPV-related oropharynx cancer who are scheduled to have surgery to remove the disease

Primary Objective(s):

- To evaluate the major pathologic response (MPR; ≤ 10% residual tumor) rate of SAR444245 combined with cemiplimab administered in the neoadjuvant setting

Secondary Objective(s):

* To evaluate the safety and tolerability of neoadjuvant SAR444245 plus cemiplimab using NCI-CTCAE version 5.0
* To evaluate the feasibility of neoadjuvant SAR444245 plus cemiplimab by assessing the percentage of patients not able to undergo the initially proposed

surgery due to disease progression or an adverse event attributed to the drug combination

* To evaluate the objective response rate (ORR) to neoadjuvant SAR444245 plus cemiplimab by RECIST 1.1 (12)
* To evaluate the proportion of patients who changed TNM stage (ie: change of TNM stage post-treatment as compared to pre-treatment) followed neoadjuvant SAR444245 plus cemiplimab
* To assess the 1-year disease-free (DFS) survival rate

Exploratory Objective(s):

* To evaluate HPV cell-free DNA as a biomarker of response to therapy
* To evaluate pre- and post- treatment tumor and blood biomarkers and correlate with pathologic and clinical response and toxicity.
* To evaluate the relationship between matched time-point RECIST criteria on anatomic imaging (T1/T2 MRI or contrast CT) with candidate functional imaging (diffusion-weighted imaging, MR relaxometry, MRI/CT radiomics), pathologic (MPR) and serum (cfDNA) novel biomarkers of therapeutic response.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study Evaluating Safety and Therapeutic Activity of THOR-707 in Adult Subjects With Advanced or Metastatic Solid Tumors (THOR-707-101)	NCT04009681	Metastasis	THOR-707 Checkpoint inhi... anti-EGFR antib...	18 Years -	Synthorx, Inc, a Sanofi company
A Study Evaluating Safety and Therapeutic Activity of THOR-707 in Adult Subjects With Advanced or Metastatic Solid Tumors (THOR-707-101)	NCT04009681	Metastasis	THOR-707 Checkpoint inhi... anti-EGFR antib...	18 Years -	Synthorx, Inc, a Sanofi company
Phase 2 Study of Neoadjuvant SAR444245 Plus Cemiplimab in HPV Related Oropharynx Squamous Cell Carcinoma	NCT05535023	Squamous Cell C... Oropharynx Canc... Head and Neck C...	SAR444245 Cemiplimab	18 Years -	M.D. Anderson Cancer Center
A Study Evaluating Safety and Therapeutic Activity of THOR-707 in Adult Subjects With Advanced or Metastatic Solid Tumors (THOR-707-101)	NCT04009681	Metastasis	THOR-707 Checkpoint inhi... anti-EGFR antib...	18 Years -	Synthorx, Inc, a Sanofi company

Spots Global Cancer Trial Database for sar444245

Every month we try and update this database with for sar444245 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for sar444245

Every month we try and update this database with for sar444245 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sar444245 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.