Advanced/ Metastatic Solid TumorsPhase 1NCT05174637

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

A Phase 1 study testing FDA018-ADC in people with Advanced/ Metastatic Solid Tumors, run by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Advanced/ Metastatic Solid Tumors
What is being tested?: FDA018-ADC
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 78 participants
Where: 1 siteChina
Study dates: 22 Oct 2021to Dec 2029
Phase: Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

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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.

Who cannot join

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;

Show all 22Show fewer

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;
Clinically active bacterial, fungal or viral infections (eg active hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV), syphilis positive and so on);
Patients who had undergone systemic high-dose steroids within 2 weeks of initiation of study treatment;
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;
Patients have history of psychotropic drug abuse, alcohol or drug abuse；
Women who are pregnant or lactating；
Any condition that is unstable or may jeopardize patient safety and its compliance with the study;
Other circumstances that is deemed not appropriate for the study.

Trial locations and contacts

1 site in 1 country.

China1 site

Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000

Other trials in China

About this study

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

Read the 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
Being tested: FDA018-ADC
Keywords: Trop-2, Solid tumor, TNBC, Antibody-drug conjugate, ADC

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FDA018-ADCDrug
Also called FDA018-Antibody-drug Conjugate, F0024
Subjects will receive an intravenous infusion of FDA018-ADC until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study.

Study groups in NCT05174637
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: FDA018-ADC

What is being measured

The primary outcome is the main question the study is designed to answer.

The dose limiting toxicity ( DLT)
Evaluated according to NCI CTCAE V5.0
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From subject randomization up to 60 months.
Recommended phase II dose (RP2D)
Measured: From subject randomization up to 60 months.

Secondary outcomes (8)

Time to peak (Tmax)
Tmax of Total Antibody, Total SN-38, Free SN-38, SN-38 Glucuronide and FDA018-ADC will be measured.
Measured: Up to 17 weeks.
Half-life time (t1/2)
t1/2 of Total Antibody, Total SN-38, Free SN-38, SN-38 Glucuronide and FDA018-ADC will be measured.
Measured: Up to 17 weeks.
Peak Plasma Concentration (Cmax)
Cmax of Total Antibody, Total SN-38, Free SN-38, SN-38 Glucuronide and FDA018-ADC will be measured.
Measured: Up to 17 weeks.
Area under the plasma concentration versus time curve (AUC)
AUC of Total Antibody, Total SN-38, Free SN-38, SN-38 Glucuronide and FDA018-ADC will be measured.
Measured: Up to 17 weeks.
Number of subjects who develop detectable anti-drug antibodies (ADAs)
The subject's ADA positive rate will be assessed By ELISA.
Measured: From subject randomization up to 60 months.
Progression free survival(PFS) according to RECIST 1.1
Progression-free survival (PFS) was defined as the interval from the first dose start date to the date of disease progression defined as documented progressive disease (PD) or death from any cause, whichever occurs first.
Measured: From subject randomization up to 60 months.
Duration of Response(DOR) according to RECIST 1.1
Duration of Response was defined as the duration of overall response measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).
Measured: From subject randomization up to 60 months.
Overall Survival (OS) according to RECIST 1.1
Overall survival was defined as the time from the date of the first dose start date to the date of death due to any cause.
Measured: From subject randomization up to 60 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Oct 2021Dec 2029

First posted3 Jan 2022
Study start22 Oct 2021
Primary completionDec 2029 (estimated)
Study completionDec 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Advanced/ Metastatic Solid TumorsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 78 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05174637
Sponsor's protocol ID: F0024-101
Status last verified: Jan 2026
First submitted: 16 Nov 2021
Last updated: 23 Jan 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 31912902
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.
PubMed 30931493
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.
PubMed 30881031
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.
PubMed 29989029

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PhaseⅠStudy to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of FDA018-ADC in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT05174637
Acronym / sponsor ID: F0024-101
Conditions: Advanced/ Metastatic Solid Tumors
Keywords: Trop-2, Solid tumor, TNBC, Antibody-drug conjugate, ADC
Phase: Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 78 participants (estimated)
Lead sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 22 Oct 2021 (actual)
Primary completion: Dec 2029 (estimated)
Study completion: Dec 2029 (estimated)
First posted: 3 Jan 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 7

Arm	Type	Receives
FDA018-ADC A mg/kg	Experimental	Drug: FDA018-ADCSubjects 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.
FDA018-ADC B mg/kg	Experimental	Drug: FDA018-ADCSubjects 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.
FDA018-ADC C mg/kg	Experimental	Drug: FDA018-ADCSubjects 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.
FDA018-ADC D mg/kg	Experimental	Drug: FDA018-ADCSubjects 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.
FDA018-ADC E mg/kg	Experimental	Drug: FDA018-ADCSubjects 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.
FDA018-ADC F mg/kg	Experimental	Drug: FDA018-ADCSubjects 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.
FDA018-ADC G mg/kg	Experimental	Drug: FDA018-ADCSubjects 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.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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;

Key exclusion criteria (22 listed)

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℃；

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FDA018-ADCAlso: FDA018-Antibody-drug Conjugate, F0024Subjects will receive an intravenous infusion of FDA018-ADC until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study.	Drug	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

Primary outcome

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.

8 secondary outcomes

Time to peak (Tmax)
Time frame: Up to 17 weeks.
Half-life time (t1/2)
Time frame: Up to 17 weeks.
Peak Plasma Concentration (Cmax)
Time frame: Up to 17 weeks.
Area under the plasma concentration versus time curve (AUC)
Time frame: Up to 17 weeks.
Number of subjects who develop detectable anti-drug antibodies (ADAs)
Time frame: From subject randomization up to 60 months.
Progression free survival(PFS) according to RECIST 1.1
Time frame: From subject randomization up to 60 months.
Duration of Response(DOR) according to RECIST 1.1
Time frame: From subject randomization up to 60 months.
Overall Survival (OS) according to RECIST 1.1
Time frame: From subject randomization up to 60 months.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
Background: PubMed 31912902Siegel 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.
Background: PubMed 30931493Ponde 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.
Background: PubMed 30881031Zaman 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.
Background: PubMed 29989029Goldenberg 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jian Zhang, Doctor principal investigator

Fudan University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing FDA018-ADC in people with Advanced/ Metastatic Solid Tumors, run by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The dose limiting toxicity ( DLT) (time frame: From first dose to the end of Cycle 1, up to 35 days.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05174637, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.