An Expansion Study to Evaluate Dose Escalation, Safety and Tolerability of SAR444881 in Patients with Advanced Solid Tumors


About this study

The purpose of this study is to evaluate the safety, tolerability, and preliminary anti-tumor activity of SAR444881 alone and in combination with pembrolizumab or with cetuximab. The study will enroll advanced cancer patients with unresectable or metastatic disease who are refractory to or are not candidates for standard approved therapy and will be comprised of two parts - an initial "3 + 3" dose escalation phase with subparts 1A (monotherapy SAR444881), 1B (SAR444881 in combination with pembrolizumab) and 1C (SAR444881 in combination with cetuximab) followed by a dose expansion phase (part 2).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Patients with unresectable or metastatic disease who are refractory to or are not
candidates for standard approved therapy

- Histologic confirmation of malignancy

- Measurable disease per RECIST v1.1

- Eastern Cooperative Oncology Group Performance Status (ECOG) of 0 or 1

- Participants must have adequate organ function as defined by lab tests

- Part 1: Following tumor types: Breast cancer, cervical cancer, colorectal cancer,
adenocarcinoma or squamous cell carcinoma of the esophagus, gastric or
gastroesophageal junction adenocarcinoma, squamous cell carcinoma of the head and
neck, hepatobiliary cancers (hepatocellular carcinoma (HCC), gallbladder cancer,
cholangiocarcinoma), non-small cell lung cancer, renal cell carcinoma, squamous cell
carcinoma of the skin, or urothelial carcinoma

- Part 2: Following tumor types: Squamous cell carcinoma of the head and neck, Gastric
or gastroesophageal junction adenocarcinoma, Non-small cell lung cancer

Exclusion Criteria:

- Active, known or suspected autoimmune disease

- Condition requiring systemic treatment with either corticosteroids or other
immunosuppressive medications

- Brain or leptomeningeal metastases

- Known history of positive test for HIV

- Non-HCC patients: acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV);
HCC patients: untreated active HBV or dual infection with HBV/HCV

- Participants after solid organ or allogeneic hematopoietic stem cell transplant

- History of life-threatening toxicity related to prior immune therapy

- History of life-threatening toxicity related to prior cetuximab or other anti-EGFR
antibodies (for Sub-Part 1C)

- Unstable or deteriorating cardiovascular disease within the previous 6 months

- Any major surgery within 4 weeks of study drug administration

- Prior/Concomitant Therapy:

- Cytotoxic/Non-cytotoxic anti-cancer agents, unless at least 4 weeks have elapsed from
last dose

- Use of other investigational drugs within 28 days

- Prior treatment with macrophage or natural killer (NK) cells activating therapies

- Administration of a live attenuated vaccine within 28 days

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 11/9/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Zhaohui Jin, M.D.

Open for enrollment

Contact information:

Chelsie Dinges

(507) 422-5403

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mitesh Borad, M.D.

Open for enrollment

Contact information:

Sarah Hernandez

(480) 342-6046

More information


Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions