A Study of EOC237 in Patients With Advanced Solid Tumor

Shanghai Yiteng Jingang Bio-pharmaceutical Technology

Status and phase: Enrolling; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Drug: EOC237

Study type: Interventional

Funder types: Industry

Identifiers

NCT05895825

EOC237-X1-101

Details and patient eligibility

About

This research study is studying an investigational drug called EOC237 in Patients With Advanced Solid Tumor.

Full description

Part 1 Dose Escalation: an open, single/multiple dose, multi-center phase I study to evaluate the safety, tolerability and pharmacokinetics of EOC237 in Patients With Advanced Solid Tumor.

Part 2 Food influence research: to assess the effect of food on the pharmacokinetics of EOC237, by investigating the bioavailability following single dose administration under fed and fasted conditions.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Advanced Solid Tumors for which standard curative or palliative measures do not exist or are no longer effective.
• Expected survival≥ 3 months.
• ECOG performance status 0-1.
• Good organ and marrow function.

Exclusion criteria

• Patients with a history of severe drug allergic reaction.
• Pregnant or lactating female subjects.
• Uncontrolled, significant intercurrent or recent illness.
• Corrected QT interval calculated by the Fridericia formula (QTcF) > 480 ms per electrocardiogram (ECG)
• Concomitant use of certain medications

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

48 participants in 3 patient groups

Part 1: Dose Escalation

Experimental group

Description:

In Part 1 (dose escalation) participants with selected advanced solid tumors will receive escalating doses of EOC237 as monotherapy. Participants can receive EOC237 until disease progression, adverse event (AE), or other discontinuation criteria, whichever occurs first.

Treatment:

Drug: EOC237

Part 2: Food influence-Group 1

Experimental group

Description:

Food influence-Group 1: EOC237 was taken orally under fasted conditions, after a 3-day washout period, EOC237 was taken orally under fed conditions. Participants can receive EOC237 until disease progression, AE, or other discontinuation criteria, whichever occurs first.

Treatment:

Drug: EOC237

Part 2: Food influence-Group 2

Experimental group

Description:

Food influence-Group 2: EOC237 was taken orally under fed conditions, after a 3-day washout period, EOC237 was taken orally under fasted conditions. Participants can receive EOC237 until disease progression, AE, or other discontinuation criteria, whichever occurs first.

Treatment:

Drug: EOC237