First-in-Human Study of EOS100850 (Inupadenant) in Patients with Cancer (IO-001)

iTeos Therapeutics

Status and phase: Completed; Phase 1

Conditions: Solid Tumor, Adult

Treatments: Drug: EOS100850; Drug: Pembrolizumab; Drug: Chemotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT03873883

2018-003173-10 (EudraCT Number)

Keynote A45 (Other Identifier)

IO-001

Details and patient eligibility

About

Multicenter, open-label, dose-escalation Phase I/Ib clinical study to evaluate the safety and tolerability, the MTD/RP2D, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of EOS100850 (Inupadenant) as a Single Agent and in Combination with Pembrolizumab and/or Chemotherapy in Participants with Advanced Cancers.

Enrollment: 119 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding participation in the Trial, please refer to your physician

Inclusion Criteria:

• Women and men ≥18 years of age with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Subject with histologically or cytologically confirmed advanced solid tumor for whom no standard treatment is further available.
• At least 4 weeks since any previous treatment for cancer
• Subject must consent to pretreatment and on treatment tumor biopsies
• Adequate organ and marrow function

Exclusion Criteria:

• Patients with primary brain tumors or primary tumors with central nervous system metastases as only location of disease. Controlled brain metastases are permitted
• Participants with second/other active cancers requiring current treatment
• Uncontrolled/significant heart disease
• Known History of chronic hepatitis, Positive test for Hepatitis B virus surface antigen or Hepatitis C antibody (except participants with liver cancer) or Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome(HIV/AIDS)
• Active/uncontrolled autoimmune disease
• Active infection

Other protocol defined inclusion/exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

119 participants in 6 patient groups

1A Dose escalation EOS100850

Experimental group

Description:

Dose Escalation- EOS100850 Monotherapy: to confirm RP2D

Treatment:

Drug: EOS100850

1B Dose escalation EOS100850 and Pembrolizumab

Experimental group

Description:

EOS100850 and Pembrolizumab Combination Therapy: to confirm RP2D as combination

Treatment:

Drug: Pembrolizumab

Drug: EOS100850

2A Dose Expansion- EOS100850

Experimental group

Description:

Dose Expansion - EOS100850 Monotherapy: to explore safety, PK, PD, and antitumor activity of inupadenant as monotherapy

Treatment:

Drug: EOS100850

2B Dose Expansion - EOS100850 and Pembrolizumab

Experimental group

Description:

Dose Expansion - EOS100850 and Pembrolizumab Combination Therapy: to explore safety, PK, PD, and antitumor activity of inupadenant in combination with pembrolizumab in melanoma and CRPC patients

Treatment:

Drug: Pembrolizumab

Drug: EOS100850

2D Dose expansion - EOS100850 and Chemotherapy in TNBC

Experimental group

Description:

Dose expansion - EOS100850 and Chemotherapy Combination: to explore safety, PK, PD, and antitumor activity of inupadenant in combination with chemotherapy SOC carboplatin and paclitaxel in patients with TNBC

Treatment:

Drug: Chemotherapy

Drug: EOS100850

3 EOS100850 in BMK-H participants

Experimental group

Description:

Dose expansion - EOS100850 Monotherapy : to evaluate the safety, PD, and antitumor activity of inupadenant as monotherapy at the mono-RP2D in BMK-H participants in 4 disease-specific cohorts: NSCLC; HNSCC; EC; and other forms of cancer

Treatment:

Drug: EOS100850