Primary:•To determine the antitumor activity of SAR444245 in combination with other anti-cancer therapies in patients with HNSCCSecondary:•To assess the safety profile of SAR444245 when combined with other anti-cancer therapies• To assess other…
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
•To determine the antitumor activity of SAR444245 in combination with other
anti-cancer therapies in patients with HNSCC
Secondary outcome
•To assess the safety profile of SAR444245 when combined with other anti-cancer
therapies
• To assess other indicators of antitumor activity.
• To assess the concentrations of SAR444245.
• To assess the immunogenicity of SAR444245.
• To confirm the dose of SAR444245 when combined with cetuximab and
pembrolizumab
(Substudy -2 Cohort A2)
• To assess the concentrations of cetuximab (Substudy 2- Cohort A2 and Substudy
5- Cohort B2)
Background summary
The is a phase 2 multi-cohort, non-randomized, open-label, multi-center study
assessing the clinical benefit of SAR444245 combined with other anticancer
therapies for the treatment of participants aged 18 years and older with HNSCC.
This study is structured as a master protocol for the investigation of
SAR444245 with other anticancer therapies.
This research consists of a core for all cohorts, with a safety run in and an
expansion phase for specific cohorts. The results from an interim analysis
after the core phase will determine if the expansion phase will be opened.
Study objective
Primary:
•To determine the antitumor activity of SAR444245 in combination with other
anti-cancer therapies in patients with HNSCC
Secondary:
•To assess the safety profile of SAR444245 when combined with other anti-cancer
therapies
• To assess other indicators of antitumor activity.
• To assess the concentrations of SAR444245.
• To assess the immunogenicity of SAR444245.
• To confirm the dose of SAR444245 when combined with cetuximab and
pembrolizumab
(Substudy -2 Cohort A2)
• To assess the concentrations of cetuximab (Substudy 2- Cohort A2 and Substudy
5- Cohort B2)
Study design
Phase 2, open-label, non-randomized, multi-cohort, multi center.
Intervention
- Investigational drugs: SAR444245 (THOR-707)
- Pharmaceutical form: concentrate for solution
- Route of administration: intravenous, infuse
Study burden and risks
Risks are related to blood withdrawal, CT or MRI scan of he brain and/of tumor,
injections of the investigational drugs and possible side effects of the drugs.
Paasheuvelweg 25
Amsterdam 1105 BP
NL
Paasheuvelweg 25
Amsterdam 1105 BP
NL
Listed location countries
Age
Inclusion criteria
- Participants must be >= 18 years of age inclusive, at the time of signing the
informed consent
- Histologically or cytologically confirmed diagnosis of R/M HNSCC that is
considered not amenable to further therapy with curative intent. The eligible
primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx
(nasopharynx is excluded)
- Measurable disease
- Baseline biopsy must be submitted for all cohort A1, A2 Core Phase
participants
- Baseline biopsy must be submitted for all cohort B1, B2 Expansion Phase
participants
- Known HPV p16 status for oropharyngeal cancer
- Participant agrees to follow protocol-specified contraception guidelines
Exclusion criteria
Participants are excluded from the study if any of the following criteria apply:
- Eastern Cooperative Oncology Group (ECOG) performance status of >=2
- Has received prior IL2-based anticancer treatment
- For participants in Cohorts A1, A2: Prior treatment with an agent (approved or
investigational) that blocks the PD-1/PD-L1 pathway (participants who joined a
study with an anti-PD-1/PD-L1 in the experimental arm but have written
confirmation they have not received anti-PD-1/PD-L1 are allowed)
- For participants in Cohorts A2, B2: Prior treatment with cetuximab (prior
cetuximab allowed if used for the treatment of locally advanced disease, with
no progressive disease for at least 4 months from completion of prior cetuximab
therapy)
- For participants in Cohorts A2, B2: Electrolytes (magnesium, calcium,
potassium) outside the normal ranges
- Participants under anti-hypertensive treatment who cannot temporarily (for at
least 36 hours) withhold antihypertensive medications prior to each IMP dosing
- Participants with baseline SpO2 <=92% (without oxygen therapy)
- 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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2021-002105-99-NL |
CCMO | NL78463.091.21 |
Other | U1111-1251-5073 |