A Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of ATG 016 Monotherapy in Patients With Advanced Solid Tumors

NCT05010525 | Terminated Phase 1

• 1 other identifier: ATG-016-ST-001
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 4

Brief Summary

This is A Phase Ib/II Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of ATG 016 Monotherapy in Patients with Advanced Solid Tumors

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (5)

• MTD in Phase I

  MTD will be evaluated using the NCI-CTCAE, Version 5.0

  16 months

• RP2D in Phase I

  RP2D will be determined under the guidance of the SRC.

  16 months

• AEs

  Toxicity will be graded according to the NCI CTCAE, Version 5.0.

  25 months

• SAEs

  Toxicity will be graded according to the NCI CTCAE, Version 5.0.

  25 months

• ORR in Phase II

  Based on 2006 IWG Response Criteria, evaluated by IRC: ORR (CR + PR + mCR)

  25 months

Secondary Outcomes (3)

• Disease Control Rate (DCR) in Phase I/II

  16 months

• Duration of Response (DOR) in Phase I/II

  12 months

• Overall Survival (OS）

  12 months

Study Arms (4)

ATG-016-20mg

EXPERIMENTAL

20 mg QD×5/ week as the initial dose in the Dose Escalation Phase, with a treatment cycle of 21 days,1-5/week will be the initial dose of this study

Drug: ATG-016

ATG-016-35mg

EXPERIMENTAL

35 mg QD×5/ week as the initial dose in the Dose Escalation Phase, with a treatment cycle of 21 days,1-5/week will be the initial dose of this study

Drug: ATG-016

ATG-016-50mg

EXPERIMENTAL

50 mg QD×5/ week as the initial dose in the Dose Escalation Phase, with a treatment cycle of 21 days,1-5/week will be the initial dose of this study

Drug: ATG-016

ATG-016-65mg

EXPERIMENTAL

65 mg QD×5/ week as the initial dose in the Dose Escalation Phase, with a treatment cycle of 21 days,1-5/week will be the initial dose of this study

Drug: ATG-016

Interventions

ATG-016 DRUG

48 patients enrolled, orally, each 3 week (21-day) a cycle

ATG-016-20mg; ATG-016-35mg; ATG-016-50mg; ATG-016-65mg

Eligibility Criteria

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

You may qualify if:

• Understand and voluntarily sign informed Consent (ICF) prior to any assessment/procedure related to study.
• Age ≥18 years at ICF signature.
• Estimated life expectancy of minimum of 12 weeks.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at ICF signature.
• Subjects must have at least one measurable lesion as defined by RECIST version 1.1.
• Females of childbearing potential must agree to use effective contraception from the time ICF signature until 180 days after the last dose. Females of childbearing potential include those who are premenopausal and those who are 2 years postmenopausal. Blood pregnancy tests must be negative for female of childbearing potential must have a negative serum pregnancy test at Screening.
• \. Histological or cytological confirmation of a solid tumor, and have progressed despite standard therapy(ies), or are intolerant to standard therapy(ies), or have no standard therapy(ies) exists.
• Penile squamous cell carcinomas confirmed by cytology or histology cannot be excised by radical surgery, or postoperative recurrence or metastasis which is not suitable for platinum chemotherapy or platinum resistance or platinum failure.
• Nasopharyngeal carcinoma

You may not qualify if:

• Subjects with any of the following conditions will not be enrolled in this study.
• Central nervous system (CNS) metastases and involvement.
• A history of bone marrow or organ transplantation.
• Prior ATG-016 administration or other XPO1 inhibitor treatment.
• Known to be allergic to the active or inactive ingredients of ATG-016 or drugs with similar chemical structure, or the subject is hypersensitive.
• Prior therapy with any investigational drugs or systemic anticancer treatment (eg, a period of 5 'half-lives' of drugs, whichever is longer) within 28 days at the time of ICF signature.
• Received extensive radiation within 28 days at the time of ICF signature or expect to undergo radical radiotherapy during the study period.
• Received major surgery within 28 days at the time of ICF signature or expect to proceed a major surgical treatment during the study period.
• Any toxicities unresolved to Grade 1 or baseline from prior anti-tumor therapy (According to NCI-CTCAE 5.0) with the exception of alopecia, within 28 days at the time of ICF signature.
• Any uncontrolled active infection requiring parenteral treatment of antibiotics, antivirals, or antifungals at the time of ICF signature or within one week of Cycle 1 Day 1 (C1D1). Active hepatitis B virus (HBV) infection (Hepatitis B surface antigen \[HBsAg\] positive) or active HCV infection (HCV-RNA positive at screening).
• A history of HIV infection and/or acquired immunodeficiency syndrome.
• Received immunosuppressive medication within 14 days at the time of ICF signature.
• Cardiovascular diseases of clinical significance
• Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
• Have a history of another primary malignancy within 5 years prior to starting study treatment, with following exceptions: malignancy tumors treated by radical therapy and have not been recurred, such as carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin, papillary thyroid carcinoma, etc.

Sponsors & Collaborators

• Shanghai Antengene Corporation Limited: lead

Study Sites (4)

The First Affiliated Hospital of Bengbu Medical College Bengbu

Bengbu, Anhui, 233099, China

Location

Chongqing Cancer Hospital

Chongqing, Chonqing, 400000, China

Location

The First Affiliated Hospital of Xiamen University

Xiaomen, Fujian, 361000, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610044, China

Location

Study Officials

• Yongsheng Wang, PhD

  Guoxue lane, Chengdu, Sichuan

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: August 18, 2021
• Study Start: September 1, 2021
• Primary Completion: November 14, 2022
• Study Completion: November 14, 2022
• Last Updated: March 17, 2023

Record last verified: 2022-07

Locations

CN (4)