NCT05174637

A PhaseⅠStudy to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of FDA018-ADC in Patients With Advanced Solid Tumors

Active, enrolled Phase 1 Last updated 21 January 2026

What this trial tests

Phase 1 trial testing FDA018-ADC in Advanced/ Metastatic Solid Tumors in 78 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

22 October 2021

Primary endpoint
1 December 2029

1 December 2029

Quick facts

Lead sponsor	Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	78
Start date	22 October 2021
Primary completion	1 December 2029
Estimated completion	1 December 2029
Sites	1 location across China

Drugs / interventions tested

• FDA018-ADC — full drug profile →

Conditions studied

• Advanced/ Metastatic Solid Tumors — all drugs for Advanced/ Metastatic Solid Tumors →

Sponsor

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. — full company profile →

Who can join

Adults 18 to 75, any sex, with Advanced/ Metastatic Solid Tumors. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• The dose limiting toxicity ( DLT)
  Time frame: From first dose to the end of Cycle 1, up to 35 days.
  Evaluated according to NCI CTCAE V5.0
• The maximum tolerated dose (MTD)
  Time frame: From first dose to the end of Cycle 1, up to 35 days.
  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.
• Adverse Events
  Time frame: From subject randomization up to 60 months
  To check the numbers of AEs happened during the course of trial.
• Objective Response Rate (ORR) according to RECIST 1.1
  Time frame: From subject randomization up to 60 months.
  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.
• Recommended phase II dose (RP2D)
  Time frame: From subject randomization up to 60 months.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Triple negative breast cancer: Pitfalls and progress.
   Zagami P, Carey LA. · · 2022 · cited 546× · PMID 35987766 · DOI 10.1038/s41523-022-00468-0
2. Trop2-targeted therapies in solid tumors: advances and future directions.
   Liu X, Ma L, Li J, Sun L, et al · · 2024 · cited 54× · PMID 38948057 · DOI 10.7150/thno.98178
3. Resistance to antibody-drug conjugates: A review.
   Li S, Zhao X, Fu K, Zhu S, et al · · 2025 · cited 32× · PMID 40177568 · DOI 10.1016/j.apsb.2024.12.036
4. Trop2-targeted therapy in breast cancer.
   Hu Y, Zhu Y, Qi D, Tang C, et al · · 2024 · cited 28× · PMID 39135109 · DOI 10.1186/s40364-024-00633-6
5. Antibody drug conjugates in the clinic.
   Udofa E, Sankholkar D, Mitragotri S, Zhao Z. · · 2024 · cited 12× · PMID 39545074 · DOI 10.1002/btm2.10677
6. Advancements in antibody-drug conjugates as cancer therapeutics.
   Fong JY, Phuna Z, Chong DY, Heryanto CM, et al · · 2025 · cited 11× · PMID 40814440 · DOI 10.1016/j.jncc.2025.01.007
7. Contemporary Approaches to Immunotherapy of Solid Tumors.
   Kuznetsova AV, Glukhova XA, Popova OP, Beletsky IP, et al · · 2024 · cited 7× · PMID 38927974 · DOI 10.3390/cancers16122270
8. The role and application of vesicles in triple-negative breast cancer: Opportunities and challenges.
   Wei YN, Yan CY, Zhao ML, Zhao XH. · · 2023 · cited 7× · PMID 38130701 · DOI 10.1016/j.omto.2023.100752