Informations générales (source: ClinicalTrials.gov)
A Phase 1/2 Study of REGN5668 (MUC16xCD28, a Costimulatory Bispecific Antibody) Administered in Combination With Other Agents in MUC16 + Malignancies
Interventional
Phase 1/Phase 2
Regeneron Pharmaceuticals (Voir sur ClinicalTrials)
décembre 2020
novembre 2027
02 décembre 2025
This study is researching an investigational drug called REGN5668 :
- alone or,
- combined with cemiplimab (also known as REGN2810) or,
- combined with both cemiplimab and fianlimab (also known as REGN3767), or
- combined with ubamatamab (also known as REGN4018), with or without sarilumab.
The main purposes of this study are to:
- Learn about the safety and profile of any side effects from the study drugs and to
determine the highest, safe dose that can be given to participants with ovarian
cancer or cancer of the uterus
- Look for signs that the study drugs can treat ovarian cancer or cancer of the uterus
This study has 2 parts. The purpose of Part 1 (Escalation) is to find the highest, safe
dose of the study drug(s). The purpose of Part 2 (Expansion) is to use the doses chosen
in Part 1. Participants with cancer of the uterus will only participate in Part 2.
The study is looking at several other research questions, including:
- Side effects that may be experienced by participants taking REGN5668 alone and/or in
combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab
- How REGN5668 works in the body either alone and/or in combination with cemiplimab,
cemiplimab and fianlimab, or ubamatamab
- How much of the study drugs (REGN5668, cemiplimab, fianlimab, ubamatamab) are in the
blood
- To see if REGN5668 in combination with cemiplimab, cemiplimab and fianlimab, or
ubamatamab works to treat cancer
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Judith MICHELS | 09/06/2026 09:05:05 | Contacter | ||
Critères
Femme
1. Ovarian Cancer Cohorts Only: Has histologically or cytologically confirmed diagnosis
of advanced epithelial ovarian cancer (except carcinosarcoma), primary peritoneal,
or fallopian tube cancer that has received at least 1 line of platinum-based
systemic therapy as defined in the protocol
2. Expansion cohorts only: Has at least 1 lesion that is measurable by RECIST 1.1 as
described in the protocol.
3. Has a serum CA-125 level ≥2x ULN (in screening, not applicable to endometrial
cohorts)
4. Has adequate organ and bone marrow function as defined in the protocol
5. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
6. Has a life expectancy of at least 3 months
7. Endometrial Cancer Cohorts Only: histologically confirmed endometrial cancer that
has progressed or recurrent after prior anti-PD-1 therapy and platinum-based
chemotherapy as described in the protocol
Key Exclusion Criteria:
1. Current or recent (as defined in the protocol) treatment with an investigational
agent, systemic biologic therapy, or anti-cancer immunotherapy
2. Has had another malignancy within the last 5 years that is progressing, requires
active treatment, or has a high likelihood of recurrence as defined in the protocol
3. Prior treatment with a Mucin 16 (MUC16)-targeted therapy
4. Ovarian Expansion cohorts only: More than 5 prior lines of systemic therapy
5. Has any condition that requires ongoing/continuous corticosteroid therapy as defined
in the protocol within 1 week prior to the first dose of study drug
6. Has ongoing or recent (within 5 years) evidence of significant autoimmune disease
that required treatment with systemic immunosuppressive treatments as defined in the
protocol
7. Has untreated or active primary brain tumor, CNS metastases, leptomeningeal disease,
or spinal cord compression as defined in the protocol
8. Has history of clinically significant cardiovascular disease as defined in the
protocol
9. Has known allergy or hypersensitivity to cemiplimab and/or components of study
drug(s).
Note: Other protocol-defined Inclusion/Exclusion criteria apply