A Study of EOC237 in Patients With Advanced Solid Tumor

NCT05895825 | Recruiting Phase 1

• 1 other identifier: EOC237-X1-101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (3)

• Proportion of subjects with dose-limiting toxicity (DLT)

  Number of subjects who experienced DLT events during 28 days after first administration of EOC237, divided by the number of DLT evaluable Subjects

  Up to approximately 3 years

• Determination of maximum tolerated dose (MTD)

  Up to approximately 3 years

• the recommended phase 2 dose (RP2D)

  Up to approximately 3 years

Study Arms (3)

Part 1: Dose Escalation

EXPERIMENTAL

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.

Drug: EOC237

Part 2: Food influence-Group 1

EXPERIMENTAL

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.

Drug: EOC237

Part 2: Food influence-Group 2

EXPERIMENTAL

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.

Drug: EOC237

Interventions

EOC237 DRUG

EOC237 for orally

Part 1: Dose Escalation; Part 2: Food influence-Group 1; Part 2: Food influence-Group 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Yiteng Jingang Bio-pharmaceutical Technology Co., Ltd: lead

Study Sites (1)

National Cancer Center/ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100029, China

RECRUITING

Central Study Contacts

Binghe Xu, MD

CONTACT

8610-87788495; cancergcp@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: June 9, 2023
• Study Start: July 26, 2023
• Primary Completion: April 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: November 2, 2023

Record last verified: 2023-05

Locations

CN (1)