A Study of FDA018-ADC in Patients With Advanced Solid Tumors

NCT ID: NCT05174637

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-22
• Study Completion Date: 2029-12-31

Brief Summary

This is a Phase 1, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics and efficacy of FDA018-ADC in patients with advanced/metastatic solid tumors.

Detailed Description

This is a first-in-human (FIH), Phase 1, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of FDA018-ADC in patients with advanced/metastatic solid tumors. FDA018-ADC is administered via intravenous infusion using an accelerated titration method followed by a conventional 3 + 3 study design to identify the maximum tolerated dose (MTD) and dose-limiting toxicities（DLT）during 35-day cycle with 3 doses. The expansion phase enrolled patients into three cohorts defined by tumor type: cohort 1 included patients with locally advanced or metastatic TNBC; cohort 2 included patients with non-small-cell lung cancer (NSCLC); and cohort 3 included those with other locally advanced or metastatic solid tumors. The efficacy and safety, as well as the recommended phase 2 dose (RP2D) were determined in this phase.

Conditions

Advanced/ Metastatic Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FDA018-ADC G mg/kg

Subjects will receive FDA018-ADC G mg/kg of body weight via intravenous (IV) infusion on Day 1 of a 14-Day cycle (Cycle 1) and on Day 1 and 8 of a 21-day cycle (Cycle 2 \~ Cycle n) in dose escalation phase, and on Day 1 and 8 of a 21-day cycle(Cycle 1 \~ Cycle n) in dose expansion phase, until the date of first documented progression or unacceptable toxicity or death.

Group Type: EXPERIMENTAL

FDA018-ADC

Intervention Type: DRUG

Subjects will receive an intravenous infusion of FDA018-ADC until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study.

FDA018-ADC A mg/kg

Subjects will receive FDA018-ADC A mg/kg of body weight via intravenous (IV) infusion on Day 1 of a 14-Day cycle (Cycle 1) and on Day 1 and 8 of a 21-day cycle (Cycle 2 \~ Cycle n) in dose escalation phase, and on Day 1 and 8 of a 21-day cycle(Cycle 1 \~ Cycle n) in dose expansion phase, until the date of first documented progression or unacceptable toxicity or death.

Group Type: EXPERIMENTAL

FDA018-ADC

Intervention Type: DRUG

Subjects will receive an intravenous infusion of FDA018-ADC until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study.

FDA018-ADC B mg/kg

Subjects will receive FDA018-ADC B mg/kg of body weight via intravenous (IV) infusion on Day 1 of a 14-Day cycle (Cycle 1) and on Day 1 and 8 of a 21-day cycle (Cycle 2 \~ Cycle n) in dose escalation phase, and on Day 1 and 8 of a 21-day cycle(Cycle 1 \~ Cycle n) in dose expansion phase, until the date of first documented progression or unacceptable toxicity or death.

Group Type: EXPERIMENTAL

FDA018-ADC

Intervention Type: DRUG

Subjects will receive an intravenous infusion of FDA018-ADC until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study.

FDA018-ADC C mg/kg

Subjects will receive FDA018-ADC C mg/kg of body weight via intravenous (IV) infusion on Day 1 of a 14-Day cycle (Cycle 1) and on Day 1 and 8 of a 21-day cycle (Cycle 2 \~ Cycle n) in dose escalation phase, and on Day 1 and 8 of a 21-day cycle(Cycle 1 \~ Cycle n) in dose expansion phase, until the date of first documented progression or unacceptable toxicity or death.

Group Type: EXPERIMENTAL

FDA018-ADC

Intervention Type: DRUG

Subjects will receive an intravenous infusion of FDA018-ADC until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study.

FDA018-ADC D mg/kg

Subjects will receive FDA018-ADC D mg/kg of body weight via intravenous (IV) infusion on Day 1 of a 14-Day cycle (Cycle 1) and on Day 1 and 8 of a 21-day cycle (Cycle 2 \~ Cycle n) in dose escalation phase, and on Day 1 and 8 of a 21-day cycle(Cycle 1 \~ Cycle n) in dose expansion phase, until the date of first documented progression or unacceptable toxicity or death.

Group Type: EXPERIMENTAL

FDA018-ADC

Intervention Type: DRUG

Subjects will receive an intravenous infusion of FDA018-ADC until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study.

FDA018-ADC E mg/kg

Subjects will receive FDA018-ADC E mg/kg of body weight via intravenous (IV) infusion on Day 1 of a 14-Day cycle (Cycle 1) and on Day 1 and 8 of a 21-day cycle (Cycle 2 \~ Cycle n) in dose escalation phase, and on Day 1 and 8 of a 21-day cycle(Cycle 1 \~ Cycle n) in dose expansion phase, until the date of first documented progression or unacceptable toxicity or death.

Group Type: EXPERIMENTAL

FDA018-ADC

Intervention Type: DRUG

Subjects will receive an intravenous infusion of FDA018-ADC until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study.

FDA018-ADC F mg/kg

Subjects will receive FDA018-ADC F mg/kg of body weight via intravenous (IV) infusion on Day 1 of a 14-Day cycle (Cycle 1) and on Day 1 and 8 of a 21-day cycle (Cycle 2 \~ Cycle n) in dose escalation phase, and on Day 1 and 8 of a 21-day cycle(Cycle 1 \~ Cycle n) in dose expansion phase, until the date of first documented progression or unacceptable toxicity or death.

Group Type: EXPERIMENTAL

FDA018-ADC

Intervention Type: DRUG

Subjects will receive an intravenous infusion of FDA018-ADC until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study.

Interventions

FDA018-ADC

Subjects will receive an intravenous infusion of FDA018-ADC until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study.

Intervention Type: DRUG

Other Intervention Names

FDA018-Antibody-drug Conjugate; F0024

Eligibility Criteria

Inclusion Criteria

1. Patients able to give written informed consent;

2. Age ≥ 18 and ≤ 75 years old, male or female;

3. Patients have histological or cytological diagnosis with advanced solid tumors, cann't benefit from existing standard treatment options, and are not suitable for surgical resection or radiation therapy for the purpose of cure; tumor types in the study include: triple-negative breast cancer (TNBC), urothelial cancer (UC), non-small-cell lung cancer (NSCLC), small-cell lung cancer (SCLC), endometrial, gastric adenocarcinoma, esophageal, ovarian, colorectal and so on.

4. Have measurable lesions defined in RECIST v. 1.1;

5. Expected survival ≥ 12 weeks;

6. Eastern Cancer Cooperative Group (ECOG) performance status 0-1;

7. Adequate bone marrow, hepatic, and renal function;

8. All acute toxicity of previous anti-tumor treatment or surgery is relieved to baseline severity or NCI CTCAE version 5.0 ≤ 1;

9. Tumor tissue sections available；

10. Patients of child bearing potential must agree to take contraception during the study and for 6 months after the last day of treatment.

Exclusion Criteria

1. Previous treatments for anti-Trop-2 antibody or other treatments against Trop-2, such as IMMU-132;

2. Have history of an anaphylactic reaction to irinotecan or ≥ Grade 3 GI toxicity to prior irinotecan, or previously allergic to macromolecular protein preparations;

3. Have had other malignant tumors in the past 5 years;

4. Received other anti-tumor treatments (including chemotherapy, radiotherapy, Targeted therapy, immunotherapy, experimental treatment and so on) within 4 weeks;

5. Infection requiring intravenous antibiotic use within 1 week or Fever of unknown cause occurred before the first administration> 38.5℃；

6. Have CNS (central nervous system) metastasis with clinical symptoms;

7. Any of the following cardiac criteria:

1. Known history of severe heart disease, such as CHF≥ level 2, NYHA≥ level 2 and angina requiring medication;

2. Clinically significant cardiac arrhythmia requiring anti-arrhythmia therapy;

3. Hypertension not controlled by medication;

8. Have history of clinical significant active COPD, or other moderate-to-severe chronic respiratory illness present within 6 months;

9. Patients with poorly controlled diabetes;

10. Suffering from active chronic inflammatory bowel disease (ulcerative colitis, Crohn disease), and history of intestinal obstruction, or GI perforation;

11. Patients who had undergone major surgery or severe trauma within 4 weeks prior to the first dose;

12. Patients who had undergone autologous within 3 months of initiation of study treatment or allogeneic organ or stem cell transplantation within 6 months of initiation of study treatment;

13. Clinically active bacterial, fungal or viral infections (eg active hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV), syphilis positive and so on);

14. Patients who had undergone systemic high-dose steroids within 2 weeks of initiation of study treatment;

15. Occurrence of serious venous/venous thrombosis within 1 year prior to the first dose, such as cerebrovascular accidents (including transient ischemic attack), deep vein thrombosis and pulmonary embolism;

16. Patients have history of psychotropic drug abuse, alcohol or drug abuse；

17. Women who are pregnant or lactating；

18. Any condition that is unstable or may jeopardize patient safety and its compliance with the study;

19. Other circumstances that is deemed not appropriate for the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jian Zhang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Countries

China

References

Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.

Reference Type: BACKGROUND

PMID: 31912902 (View on PubMed)

Ponde N, Aftimos P, Piccart M. Antibody-Drug Conjugates in Breast Cancer: a Comprehensive Review. Curr Treat Options Oncol. 2019 Apr 1;20(5):37. doi: 10.1007/s11864-019-0633-6.

Reference Type: BACKGROUND

PMID: 30931493 (View on PubMed)

Zaman S, Jadid H, Denson AC, Gray JE. Targeting Trop-2 in solid tumors: future prospects. Onco Targets Ther. 2019 Mar 1;12:1781-1790. doi: 10.2147/OTT.S162447. eCollection 2019.

Reference Type: BACKGROUND

PMID: 30881031 (View on PubMed)

Goldenberg DM, Stein R, Sharkey RM. The emergence of trophoblast cell-surface antigen 2 (TROP-2) as a novel cancer target. Oncotarget. 2018 Jun 22;9(48):28989-29006. doi: 10.18632/oncotarget.25615. eCollection 2018 Jun 22.

Reference Type: BACKGROUND

PMID: 29989029 (View on PubMed)

Other Identifiers

F0024-101

Identifier Type: -

Identifier Source: org_study_id