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AzTrials

Oesophageal Squamous Cell CarcinomaPhase 2NCT05104567

A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With Gastrointestinal Cancer (Master Protocol) (Pegathor Gastrointestinal 203)

A Phase 2 study testing THOR-707, Pembrolizumab and Cetuximab in people with Oesophageal Squamous Cell Carcinoma and Gastric Cancer, run by Sanofi at 29 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The study is a phase 2 non-randomized, open-label, multi-cohort, multi-center study assessing the clinical benefit of SAR444245 (THOR-707) combined with other anticancer therapies for the treatment of participants aged 18 years and older with advanced and metastatic gastrointestinal cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
THOR-707, Pembrolizumab and Cetuximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
138 participants
Where
29 sitesin 9 countries
Study dates
9 Dec 2021to 9 Sep 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant must be ≥18 years of age (or country's legal age of majority if >18 years), at the time of signing the informed consent.
  • Participants with:
  • Sub-study01: Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic esophageal cancer of the squamous cell carcinoma subtype.
  • Sub-study02: Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic GC or Siewert Type 2 \& 3 GEJ.
  • Sub-study03: Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic hepatocellular carcinoma (HCC), or clinically by AASLD criteria in cirrhotic patients.
  • Sub-study04: Histologically or cytologically confirmed diagnosis of advanced unresectable or mCRC. Only patients with non-MSI-H disease are eligible.
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  • Participants (all sub-studies) must have at least one measurable lesion.
  • Mandatory baseline biopsy for the first 20 participants to enroll in sub-study01, sub-study02 and sub-study04. On-treatment biopsy for at least 20 participants in sub-study04. On-treatment biopsies are otherwise optional per Investigator's discretion for the other cohorts.
  • Females are eligible to participate if they are not pregnant or breastfeeding, not a woman of childbearing potential (WOCBP) or are a WOCBP that agrees:
  • to use approved contraception method and submit to regular pregnancy testing prior to treatment and for at least 120 days (for Cohort A, B1, B2, B3, C, and D1) or 60 days (for Cohort D2) [corresponding to the time needed to eliminate any study intervention(s)].
  • and to refrain from donating or cryopreserving eggs for 120 days after discontinuing study treatment.
  • Males are eligible to participate if they agree to refrain from donating or cryopreserving sperm, and either abstain from heterosexual intercourse OR use approved contraception during study treatment and for at least 3 days [corresponding to time needed to eliminate SAR444245] after the last dose of SAR444245.
  • Capable of giving signed informed consent.

Who cannot join

  • Eastern Cooperative Oncology Group (ECOG) performance status of ≥2.
  • Poor organ function.
  • Active brain metastases or leptomeningeal disease.
  • History of allogenic or solid organ transplant.
  • Last administration of prior antitumor therapy or any investigational treatment within 28 days or less than 5 times the half-life, whichever is shorter; major surgery within 28 days prior to first IMP administration.
  • Comorbidity requiring corticosteroid therapy (>10 mg prednisone/day or equivalent) within 2 weeks of IMP initiation. Inhaled or topical steroids are permitted, provided that they are not for treatment of an autoimmune disorder. Participants who require a brief course of steroids (eg, as prophylaxis for imaging studies due to hypersensitivity to contrast agents) are not excluded).
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  • Antibiotic use (excluding topical antibiotics) ≤14 days prior to first dose of IMP.
  • Severe or unstable cardiac condition within 6 months prior to starting study treatment.
  • Active, known, or suspected autoimmune disease that has required systemic treatment in the past 2 years.
  • Participants with baseline SpO2 ≤92% (without oxygen therapy). - Participant has received prior IL2-based anticancer treatment.
  • Participants on sub-study02 cohort B1 and B2 or sub-study 04 - cohort D1 with prior treatment with an agent that blocks the PD-1/PD-L1 pathway.
  • Receipt of a live-virus or live attenuated-virus vaccination within 28 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial locations and contacts

29 sites in 9 countries.

29 sites in 9 countries

Spain7 sites

  • Investigational Site Number : 7240002

    Barcelona, Barcelona [Barcelona], 08035

  • Investigational Site Number : 7240006

    Barcelona, Barcelona [Barcelona], 08036

  • Investigational Site Number : 7240101

    Madrid, Madrid, Comunidad de, 28027

  • Investigational Site Number : 7240003

    Madrid / Madrid, Madrid, Comunidad de, 28007

  • Investigational Site Number : 7240004

    Madrid / Madrid, Madrid, Comunidad de, 28050

  • Investigational Site Number : 7240001

    Pamplona, Navarre, 31008

  • Investigational Site Number : 7240005

    Santander, Cantabria, 39008

Other trials in Spain

France5 sites

  • Investigational Site Number : 2500004

    Bordeaux, 33075

  • Investigational Site Number : 2500006

    Brest, 29200

  • Investigational Site Number : 2500002

    Paris, 75015

  • Investigational Site Number : 2500005

    Poitiers, 86021

  • Investigational Site Number : 2500001

    Villejuif, 94800

Other trials in France

South Korea4 sites

  • Investigational Site Number : 4100002

    Seoul, Seoul-teukbyeolsi, 03080

  • Investigational Site Number : 4100004

    Seoul, Seoul-teukbyeolsi, 03722

  • Investigational Site Number : 4100001

    Seoul, Seoul-teukbyeolsi, 05505

  • Investigational Site Number : 4100003

    Seoul, Seoul-teukbyeolsi, 06351

Other trials in South Korea

United States3 sites

  • City of Hope Site Number : 8400007

    Duarte, California, 91010

  • AdventHealth Orlando Site Number : 8400005

    Orlando, Florida, 32804

  • Seattle Cancer Care Alliance Site Number : 8400009

    Seattle, Washington, 98115

Other trials in United States

Belgium3 sites

  • Investigational Site Number : 0560002

    Brussels, BE-1200

  • Investigational Site Number : 0560003

    Edegem, 2650

  • Investigational Site Number : 0560001

    Leuven, 3000

Other trials in Belgium

Italy3 sites

  • Investigational Site Number : 3800003

    Milan, 20132

  • Investigational Site Number : 3800002

    Milan, 20133

  • Investigational Site Number : 3800001

    Rozzano, Lombardy, 20089

Other trials in Italy

Netherlands2 sites

  • Investigational Site Number : 5280001

    Amsterdam, 1081 HV

  • Investigational Site Number : 5280003

    Rotterdam, 3015 GD

Other trials in Netherlands

Chile1 site

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 8420383

Other trials in Chile

China1 site

  • Investigational Site Number : 1560002

    Wuhan, 430022

Other trials in China

About this study

Official title: A Phase 2 Non-randomized, Open-label, Multi-cohort, Multi-center Study Assessing the Clinical Benefit of SAR444245 (THOR-707) Combined With Other Anticancer Therapies for the Treatment of Participants With Advanced and Metastatic Gastrointestinal Cancer

The study is a phase 2 non-randomized, open-label, multi-cohort, multi-center study assessing the clinical benefit of SAR444245 (THOR-707) combined with other anticancer therapies for the treatment of participants aged 18 years and older with advanced and metastatic gastrointestinal cancer. This study is structured as a master protocol for the investigation of SAR444245 with other anticancer therapies.

Sub study 01 - Cohort A aims to establish proof-of-concept that combining the non-alpha-IL2 SAR444245 with the anti-PD1 antibody pembrolizumab will result in a significant increase in the percentage of patients experiencing an objective response in the setting of advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC).

Read more

Sub study 02 - Cohort B1, B2 and B3 would focus on non MSI-H tumors with a large unmet need to establish proof-of-concept that combining the non-alpha-IL2 SAR444245 with the anti-PD1 antibody pembrolizumab will result in a significant increase in the percentage of patients experiencing an objective response in the setting of advanced unresectable or metastatic gastric cancer or gastro-esophageal junction adenocarcinoma (GC/GEJ), especially with low PD-L1 expression or after progression on prior PD1/PD-L1-based regimens.

Sub study 03 - Cohort C aims to establish proof-of-concept that combining the non-alpha-IL2 SAR444245 with the anti-PD1 antibody pembrolizumab will result in a significant increase in the percentage of patients experiencing an objective response in participants with advanced unresectable or metastatic HCC who relapsed on prior PD1/PD-L1-based regimens.

Sub study 04 - Cohort D1 and D2 aims to establish proof-of-concept that combining the non-alpha-IL2 SAR444245 with either the anti-PD1 antibody pembrolizumab or with the anti-EGFR IgG1 antibody cetuximab will result in a significant increase in the percentage of patients experiencing an objective response in the setting of advanced unresectable or metastatic colorectal cancer (mCRC).

Read the detailed description

The duration of the study for an individual patient will start from the signature of the main informed consent and include a screening period of up to 28 days, a treatment period [max 35 cycles {cohort A; B1,B2, B3, C and D1} = 735 days or until PD {cohort D2}], an end-of-treatment visit at least 30 days following the last administration of study drug (or until the patient receives another anticancer therapy, whichever is earlier), and a follow-up visit 3 months after treatment discontinuation and every 3 months following, until disease progression, or initiation of another antitumor treatment, or death, whichever is earlier.

Being tested
THOR-707, Pembrolizumab, Cetuximab
Medical subject headings
Esophageal Squamous Cell Carcinoma, Stomach Neoplasms, Carcinoma, Hepatocellular, Colorectal Neoplasms, Adenocarcinoma Of Esophagus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • THOR-707Drug

    Also called Pegenzileukin

    Solution for infusion: intravenous infusion

  • PembrolizumabDrug

    Also called KEYTRUDA®

    Solution for infusion: intravenous infusion

  • CetuximabDrug

    Also called ERBITUX®

    Solution for infusion: intravenous infusion

Study groups in NCT05104567
Study groupRoleWhat they receive
Cohort A: ESCC Post PD-1/PD-L1; SAR444245 24 mcg/kg + Pembrolizumab as 2/3L TherapyExperimentalParticipants with advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC), regardless of programmed cell death-ligand 1 (PD-L1) expression (any combined positive score [CPS]), who had received at least 1 but no more than 2 prior lines of treatment and had progressed after primary or secondary resistance to an anti-programmed cell death-1 (PD-1)/PD-L1 based regimen were included in this cohort. Participants received SAR444245 24 microgram per kilogram (mcg/kg) along with pembrolizumab 200 milligram (mg) via intravenous (IV) infusion every 3 weeks (q3w) on Day 1 of each cycle (each cycle is 21 days) (as second-line or third-line [2/3L] therapy), until disease progression (PD), unacceptable adverse event (AE) or other full permanent discontinuation criteria was met or completion of Cycle 35.
Receives: Drug: THOR-707; Drug: Pembrolizumab
Cohort B1: GC/GEJ PD-1/PD-L1 naïve non-MSI-H CPS >=1ExperimentalCohort B1: GC/GEJ PD-1/PD-L1 naïve non-MSI-H CPS >=1; SAR444245 24mcg/kg+Pembrolizumab as 1-3L Therapy. Participants with advanced unresectable or metastatic gastric cancer (GC) or Siewert Type 2 \& 3 gastro-esophageal junction adenocarcinoma (GEJ) and for whom standard of care (SOC) was not in best interest or where no SOC was established, non-high-level microsatellite instability (MSI-H) disease and had not received more than 2 prior lines of treatment that did not include an anti-PD-1/PD-L1-based regimen with the level of PD-L1 expression at baseline as CPS >=1 GC/GEJ were included in this cohort. Participants received SAR444245 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as first to [1-]3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Receives: Drug: THOR-707; Drug: Pembrolizumab
Cohort B2: GC/GEJ PD-1/PD-L1 naïve non-MSI-H CPS <1ExperimentalCohort B2: GC/GEJ PD-1/PD-L1 naïve non-MSI-H CPS <1; SAR444245 24 mcg/kg+Pembrolizumab as 1-3L Therapy. Participants with advanced unresectable or metastatic GC or Siewert Type 2 \& 3 GEJ and for whom SOC was not in best interest or where no SOC was established, non-MSI-H disease and had not received more than 2 prior lines of treatment that did not include an anti-PD-1/PD-L1-based regimen with the level of PD-L1 expression at baseline as CPS <1 GC/GEJ were included in this cohort. Participants received SAR444245 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Receives: Drug: THOR-707; Drug: Pembrolizumab
Cohort B3: GC/GEJ Post PD-1/PD-L1 non-MSI-H; SAR444245 24 mcg/kg + Pembrolizumab as 2-4L TherapyExperimentalParticipants with advanced unresectable or metastatic GC or Siewert Type 2 \& 3 GEJ and for whom SOC was not in best interest or where no SOC was established, non-MSI-H disease and had received atleast 1 and no more than 3 prior lines of treatment and had progressed after primary or secondary resistance to an anti-PD-1/PD-L1-based regimen (regardless of the disease CPS status) were included in this cohort. Participants received SAR444245 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 2-fourth [4]L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Receives: Drug: THOR-707; Drug: Pembrolizumab
Cohort C: HCC Post PD-1/PD-L1; SAR444245 24 mcg/kg + Pembrolizumab as 2/3L TherapyExperimentalParticipants with advanced unresectable or metastatic hepatocellular carcinoma (HCC), regardless of any CPS, who relapsed on prior PD-1/PD-L1-based regimens, with at least stable disease (SD) as best response and with no more than 2 prior lines of treatment were included in this cohort. Participants received SAR444245 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Receives: Drug: THOR-707; Drug: Pembrolizumab
Cohort D1: CRC non-MSI-H any RAS; SAR444245 24 mcg/kg + Pembrolizumab as 3-6L TherapyExperimentalParticipants with advanced unresectable or metastatic colorectal cancer (CRC), regardless of any CPS, non-MSI-H disease, any RAS type, who had progressed on prior regimens having contained fluoropyrimidine, oxaliplatin, irinotecan, with either bevacizumab or cetuximab, and with no more than 5 prior lines of treatments were included in this cohort. Participants received SAR444245 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 3-sixth [6]L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Receives: Drug: THOR-707; Drug: Pembrolizumab
Cohort D2: CRC non-MSI-H RAS Wild Type; SAR444245 24 mcg/kg + Cetuximab as 3-6L TherapyExperimentalParticipants with advanced unresectable or metastatic CRC, regardless of any CPS, non-MSI-H disease, RAS wild type, who had progressed on prior regimens having contained fluoropyrimidine, oxaliplatin, irinotecan, with either bevacizumab or cetuximab, and with no more than 5 prior lines of treatments were included in this cohort. Participants received SAR444245 24 mcg/kg q3w on Day 1 of each cycle along with cetuximab as an initial loading dose of 400 mg/square meter (m^2) on Cycle 1 Day 1 followed by 250 mg/m^2 starting via IV infusion once weekly from Cycle 1 Day 8 (each cycle is 21 days) (as 3-6L therapy) until PD.
Receives: Drug: THOR-707; Drug: Cetuximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cohort A: Objective Response Rate (ORR)

    ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to <10 millimeter (mm) (<1 centimeter [cm]). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 8 months

  2. Cohorts B1, B2 and B3: Objective Response Rate

    ORR was defined as the percentage of participants who had a confirmed CR or PR as per RECIST v 1.1. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to <10 mm (<1 cm). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 25 months

  3. Cohort C: Objective Response Rate

    ORR was defined as the percentage of participants who had a confirmed CR or PR as per RECIST v 1.1. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to <10 mm (<1 cm). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 20 months

  4. Cohorts D1 and D2: Objective Response Rate

    ORR was defined as the percentage of participants who had a confirmed CR or PR as per RECIST v 1.1. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to <10 mm (<1 cm). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 8 months

Secondary outcomes (15)

  1. All Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

    An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was any AE that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. TEAEs were defined as AEs that developed, worsened (according to the Investigator's opinion) or became serious during the TE period.

    Measured: From first dose of study treatment administration (Day 1) up to 30 days post last dose of study treatment administration, up to approximately 9 months (Cohorts A, D1 and D2), 26 months (Cohorts B1, B2 and B3) and 21 months (Cohort C)

  2. All Cohorts: Time to Response (TTR)

    TTR was defined as the time from the date of first study treatment administration to the first tumor assessment at which the overall response was recorded as PR or CR that was subsequently confirmed as per RECIST v 1.1. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to <10 mm (<1 cm). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 8 months (Cohort A, D1 and D2), 25 months (Cohort B1, B2 and B3), 20 months (Cohort C)

  3. All Cohorts: Duration of Response (DOR)

    DOR was defined as the time from the date of first tumor assessment at which the overall response was recorded as CR or PR that was subsequently confirmed to the date of first documentation of objective PD before the initiation of any post-treatment anti-cancer therapy or death due to any cause, whichever occurred first, as per RECIST v 1.1. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to <10 mm (<1 cm). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study), in addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm (0.5 cm).

    Measured: From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 8 months (Cohort A, D1 and D2), 25 months (Cohort B1, B2 and B3), 20 months (Cohort C)

  4. All Cohorts: Clinical Benefit Rate (CBR)

    CBR was defined as the percentage of participants with clinical benefit (confirmed CR or PR as best overall response [BOR], or SD lasting at least 6 months), as per RECIST v 1.1. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to <10 mm (<1 cm). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. BOR was defined as the best response recorded from the start of the study treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

    Measured: From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 8 months (Cohort A, D1 and D2), 25 months (Cohort B1, B2 and B3), 20 months (Cohort C)

  5. All Cohorts: Progression-Free Survival (PFS)

    PFS was defined as the time from the date of first study treatment to the date of the first documentation of objective PD or death due to any cause, whichever occurred first, as per RECIST v 1.1. PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study), in addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm (0.5 cm).

    Measured: From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 8 months (Cohort A, D1 and D2), 25 months (Cohort B1, B2 and B3), 20 months (Cohort C)

  6. Maximum Concentration Observed (Cmax) of Pegenzileukin

    Blood samples were collected at specified timepoints for the assessment of Cmax of pegenzileukin. The pharmacokinetic (PK) parameters were calculated using non-compartmental method.

    Measured: Day 1 Cycle 1 and Day 1 Cycle 4 (each cycle is 21 days)

  7. Last Concentration Observed Above the Lower Limit of Quantification (Clast) of Pegenzileukin

    Blood samples were collected at specified timepoints for the assessment of Clast of pegenzileukin. The PK parameters were calculated using non-compartmental method.

    Measured: Day 1 Cycle 1 and Day 1 Cycle 4 (each cycle is 21 days)

  8. Time of the Last Concentration Observed Above the Lower Limit of Quantification (Tlast) of Pegenzileukin

    Blood samples were collected at specified timepoints for the assessment of tlast of pegenzileukin. The PK parameters were calculated using non-compartmental method.

    Measured: Day 1 Cycle 1 and Day 1 Cycle 4 (each cycle is 21 days)

  9. Area Under the Plasma Concentration Versus Time Curve Calculated Using the Trapezoidal Method From Time Zero to Tlast (AUClast) of Pegenzileukin

    Blood samples were collected at specified timepoints for the assessment of AUClast of pegenzileukin. The PK parameters were calculated using non-compartmental method.

    Measured: Day 1 Cycle 1 and Day 1 Cycle 4 (each cycle is 21 days)

  10. Area Under the Concentration Versus Time Curve Extrapolated to Infinity (AUC) of Pegenzileukin

    Blood samples were collected at specified timepoints for the assessment of AUC of pegenzileukin. The PK parameters were calculated using non-compartmental method.

    Measured: Day 1 Cycle 1 and Day 1 Cycle 4 (each cycle is 21 days)

  11. Observed Accumulation Ratio (Rac) of Pegenzileukin

    Blood samples were collected at specified timepoints for the assessment of Rac of pegenzileukin. Rac was calculated as AUC at Cycle 4 Day 1/AUC at Cycle 1 Day 1. The PK parameters were calculated using non-compartmental method.

    Measured: Day 1 Cycle 1 and Day 1 Cycle 4 (each cycle is 21 days)

  12. Observed Accumulation Ratio Based on Cmax (Rac,Cmax) of Pegenzileukin

    Blood samples were collected at specified timepoints for the assessment of Rac,cmax of pegenzileukin. Rac,cmax was calculated as Cmax at Cycle 4 Day 1/Cmax at Cycle 1 Day 1. The PK parameters were calculated using non-compartmental method.

    Measured: Day 1 Cycle 1 and Day 1 Cycle 4 (each cycle is 21 days)

  13. Cohort D2: Concentration Observed Just Before Intervention Administration During Repeated Dosing (Ctrough) of Cetuximab

    Blood samples were collected at specified timepoints for the assessment of Ctrough of Cetuximab. The PK parameters were calculated using non-compartmental method.

    Measured: Cycles 1, 2, 3, 4, 6 and 8 (each cycle is 21 days)

  14. Cohort D2: Concentration at End of Infusion (Ceoi) of Cetuximab

    Blood samples were collected at specified timepoints for the assessment of Ceoi of Cetuximab. The PK parameters were calculated using non-compartmental method.

    Measured: Cycles 1, 2, 3, 4, 6 and 8 (each cycle is 21 days)

  15. All Cohorts: Number of Participants With Anti-Drug Antibodies (ADAs) Against Pegenzileukin

    Blood samples were collected at specified timepoints to assess the presence of ADA against pegenzileukin. Treatment-emergent ADA was defined as at least one treatment-induced or treatment-boosted ADA. Treatment-induced ADA was defined as ADA that developed during the TE period and without pre-existing ADA (including participants without pre-treatment samples). Treatment-boosted ADA was defined as pre-existing ADA that was boosted during the TE period to a significant higher titer than the baseline. Number of participants with treatment-emergent ADA is presented.

    Measured: From first dose of study treatment administration (Day 1) up to 30 days post last dose of study treatment administration, up to approximately 9 months (Cohorts A, D1 and D2), 26 months (Cohorts B1, B2 and B3) and 21 months (Cohort C)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2021
  2. Study start9 Dec 2021
  3. Primary completion26 Jul 2023
  4. Study completion9 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
138 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05104567
Sponsor's protocol ID
ACT16902
Other IDs
U1111-1251-4981, MK-3475-B78, KEYNOTE-B78, 2021-002181-41
Status last verified
Sep 2025
First submitted
21 Oct 2021
Last updated
24 Sep 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • Harris WP, Garcia-Alfonso P, Metges JP, Cubillo-Gracian A, Zaanan A, Carlos LL, Ronzoni M, Ponz-Sarvise M, Baakili A, Kefsi A, Andrieu L, Agrawal M, Wang W, Paehler T, Abbadessa G, Van Cutsem E. Evaluating pegenzileukin (SAR444245/THOR-707) in combination with pembrolizumab or cetuximab in advanced metastatic gastrointestinal cancer: the PEGATHOR phase 2 study. Invest New Drugs. 2026 Jun 22. doi: 10.1007/s10637-026-01622-2. Online ahead of print.

    PubMed 42329347

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing THOR-707, Pembrolizumab and Cetuximab in people with Oesophageal Squamous Cell Carcinoma and Gastric Cancer, run by Sanofi at 29 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in Spain, France, South Korea, United States, Belgium and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohort A: Objective Response Rate (ORR) (time frame: From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 8 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05104567, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.

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