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

NCT05174637 | Active Not Recruiting Phase 1

• 1 other identifier: F0024-101
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced/ Metastatic Solid Tumors

Keywords

Trop-2; Solid tumor; TNBC; Antibody-drug conjugate, ADC

Outcome Measures

Primary Outcomes (5)

• The dose limiting toxicity ( DLT)

  Evaluated according to NCI CTCAE V5.0

  From first dose to the end of Cycle 1, up to 35 days.

• The maximum tolerated dose (MTD)

  Maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 or more in a cohort of either 3 or 6 patients experiences a dose limiting toxicity (DLT) attributed to FDA018.

  From first dose to the end of Cycle 1, up to 35 days.

• Adverse Events

  To check the numbers of AEs happened during the course of trial.

  From subject randomization up to 60 months

• Objective Response Rate (ORR) according to RECIST 1.1

  ORR was defined as the rate an overall best response of either complete response (CR) or partial response (PR) according to RECIST1.1. CR was defined as the disappearance of all target lesions and reduction in short axis of any pathologic lymphnode to \<10 mm. PR was defined as ≥ 30% decrease in the sum of diameters of target lesions, taking the baseline sum diameters.

  From subject randomization up to 60 months.

• Recommended phase II dose (RP2D)

  From subject randomization up to 60 months.

Secondary Outcomes (8)

• Time to peak (Tmax)

  Up to 17 weeks.

• Half-life time (t1/2)

  Up to 17 weeks.

• Peak Plasma Concentration (Cmax)

  Up to 17 weeks.

• Area under the plasma concentration versus time curve (AUC)

  Up to 17 weeks.

• Number of subjects who develop detectable anti-drug antibodies (ADAs)

  From subject randomization up to 60 months.

Study Arms (7)

FDA018-ADC A mg/kg

EXPERIMENTAL

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.

Drug: FDA018-ADC

FDA018-ADC B mg/kg

EXPERIMENTAL

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.

Drug: FDA018-ADC

FDA018-ADC C mg/kg

EXPERIMENTAL

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.

Drug: FDA018-ADC

FDA018-ADC D mg/kg

EXPERIMENTAL

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.

Drug: FDA018-ADC

FDA018-ADC E mg/kg

EXPERIMENTAL

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.

Drug: FDA018-ADC

FDA018-ADC F mg/kg

EXPERIMENTAL

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.

Drug: FDA018-ADC

FDA018-ADC G mg/kg

EXPERIMENTAL

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.

Drug: FDA018-ADC

Interventions

FDA018-ADC DRUG

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

Also known as: FDA018-Antibody-drug Conjugate, F0024

FDA018-ADC A mg/kg; FDA018-ADC B mg/kg; FDA018-ADC C mg/kg; FDA018-ADC D mg/kg; FDA018-ADC E mg/kg; FDA018-ADC F mg/kg; FDA018-ADC G mg/kg

Eligibility Criteria

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

You may qualify if:

• Patients able to give written informed consent;
• Age ≥ 18 and ≤ 75 years old, male or female;
• 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.
• Have measurable lesions defined in RECIST v. 1.1;
• Expected survival ≥ 12 weeks;
• Eastern Cancer Cooperative Group (ECOG) performance status 0-1;
• Adequate bone marrow, hepatic, and renal function;
• All acute toxicity of previous anti-tumor treatment or surgery is relieved to baseline severity or NCI CTCAE version 5.0 ≤ 1;
• Tumor tissue sections available；
• Patients of child bearing potential must agree to take contraception during the study and for 6 months after the last day of treatment.

You may not qualify if:

• Previous treatments for anti-Trop-2 antibody or other treatments against Trop-2, such as IMMU-132;
• Have history of an anaphylactic reaction to irinotecan or ≥ Grade 3 GI toxicity to prior irinotecan, or previously allergic to macromolecular protein preparations;
• Have had other malignant tumors in the past 5 years;
• Received other anti-tumor treatments (including chemotherapy, radiotherapy, Targeted therapy, immunotherapy, experimental treatment and so on) within 4 weeks;
• Infection requiring intravenous antibiotic use within 1 week or Fever of unknown cause occurred before the first administration\> 38.5℃；
• Have CNS (central nervous system) metastasis with clinical symptoms;
• Any of the following cardiac criteria:
• Known history of severe heart disease, such as CHF≥ level 2, NYHA≥ level 2 and angina requiring medication;
• Clinically significant cardiac arrhythmia requiring anti-arrhythmia therapy;
• Hypertension not controlled by medication;
• Have history of clinical significant active COPD, or other moderate-to-severe chronic respiratory illness present within 6 months;
• Patients with poorly controlled diabetes;
• Suffering from active chronic inflammatory bowel disease (ulcerative colitis, Crohn disease), and history of intestinal obstruction, or GI perforation;
• Patients who had undergone major surgery or severe trauma within 4 weeks prior to the first dose;
• 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;

Sponsors & Collaborators

• Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200000, China

Location

Related Publications (4)

• 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.

  PMID: 31912902 BACKGROUND

• 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.

  PMID: 30931493 BACKGROUND

• 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.

  PMID: 30881031 BACKGROUND

• 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.

  PMID: 29989029 BACKGROUND

Study Officials

• Jian Zhang, Doctor

  Fudan University

  PRINCIPAL INVESTIGATOR

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: November 16, 2021
• First Posted: January 3, 2022
• Study Start: October 22, 2021
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)