Advanced Malignant TumorPhase 1NCT04739111

An Exploratory Clinical Study of LDP Combined With CDP1 in Patients With Advanced Malignant Tumor

A Phase 1 study testing Human Anti-PD-L1 Monoclonal Antibody Injection (LDP) Combined with Recombinant Anti-EGFR Human Mouse Chimeric Monoclonal Antibody Injection (CDP1) in people with Advanced Malignant Tumor, run by Dragonboat Biopharmaceutical Company Limited at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is an exploratory clinical study of Human Anti-PD-L1 Monoclonal Antibody Injection (LDP) combined with Recombinant Anti-EGFR Human Mouse Chimeric Monoclonal Antibody Injection (CDP1) in patients with advanced malignant tumor. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Malignant Tumor
What is being tested?: Human Anti-PD-L1 Monoclonal Antibody Injection (LDP) Combined with Recombinant Anti-EGFR Human Mouse Chimeric Monoclonal Antibody Injection (CDP1)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteChina
Study dates: 29 Jan 2021to 5 Sep 2022
Phase: Phase 1
Are there results?: None posted in the registry

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

1. Age ≥ 18 (inclusive), no gender limitation;
2. The estimated survival time is more than 3 months.
3. At least one assessable tumor lesion according to RECIST1.1 (in cohort 1, evaluate lesion is accept);
4. ECOG physical strength score 0-2;
5. No serious abnormal blood system, liver function, kidney function or coagulation function: ANC≥1.5×109 / L, PLT≥75×109 / L, Hb≥9g/dL; TBIL≤1.5×ULN, ALT≤2.5×ULN, AST≤2.5×ULN; Cr ≤ 1.5 × ULN, and creatinine clearance ≥ 50 ml /min(according to Croft Gault formula),Urinary protein ≤2+;or 24-hour urinary protein ≤1g; APTT≤ 1.5 ×ULN, PT ≤ 1.5 × ULN, INR ≤ 1.5 × ULN;"
6.Blood or urine pregnancy tests are negative in women of childbearing age within 7 days before the first dose.Male subjects and female subjects of reproductive age must use adequate contraception and have no plans to donate sperm or eggs within 3 months from the date of signing informed consent for the study to the date of the last study drug treatment.
7. Subjects must give informed consent to this study before the study, and voluntarily sign a written informed consent;
8.Locally advanced or metastatic malignancies diagnosed by histopathology, which have failed standard treatment, have no standard treatment regimen, or are not suitable for standard treatment at this stage. In the dose-expansion phase: cohort 1: head and neck squamous cell carcinoma;Cohort 2: colorectal cancer, RAS genotype was wild type;Cohort 3: esophageal squamous cell carcinoma;Cohort 4: Penile cancer;Cohort 5: Female reproductive system tumors (endometrial, cervical, ovarian).

Who cannot join

1. Received radiotherapy, chemotherapy, targeted therapy, endocrine therapy or immunotherapy within 4 weeks before the first administration, or other unlisted clinical trial drug therapy (mitomycin and nitrosourea are 6 weeks from the last administration, oral fluorouracil drugs such as tegiol and capecitabine are at least 2 weeks from the last administration, small molecule targeted drugs are at least 2 weeks or at least interval 5 half-life (Subject to the longer time) from the last administration, and traditional Chinese medicine with antitumor indications are at least 2 weeks from the last administration.
2. Major organ surgery (excluding puncture biopsy) or significant trauma occurred within 4 weeks prior to the first administration.
3. The adverse effects of previous antitumor therapy have not recovered to CTCAE 5.0 ≤grade1 (except for alopecia)
4. Patients with clinical symptoms of brain metastases, spinal cord compression, cancerous meningitis, or other evidence of uncontrolled brain or spinal cord metastases are not suitable for inclusion as judged by the investigator
5. Patients who had previously received PD-1 or PD-L1 inhibitors or anti-EGFR monoclonal antibody or other immune checkpoint inhibitors and failed;
6. Immunorelated adverse events ≥ Grade 3 were observed in previous immunotherapy;

Show all 16Show fewer

7. Patients with active or previous autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, interstitial lung disease, etc.);
8. Patients who received systemic corticosteroid (prednisone > 10mg/ day or equivalent) or other immunosuppressive therapy within 14 days prior to initial dosing; Exceptions include: topical, ocular, intraarticular, intranasal, and inhaled corticosteroids;Short-term use of corticosteroids for preventive treatment;
9. Uncontrolled active hepatitis B (HBsAg positive with HBV DNA copy number > 103/ mL or HBV DNA titer >200 IU/ mL); Hepatitis C;Syphilis infection (syphilis antibody positive) and HIV positive patients.
10. A history of serious cardiovascular disease, including ventricular arrhythmias requiring clinical intervention;Acute coronary syndrome, congestive heart failure, stroke, or other grade 3 or higher cardiovascular events within 6 months;New York Heart Association (NYHA) cardiac function grade ≥II or left ventricular ejection fraction (LVEF) < 50%;Patients with clinically uncontrolled hypertension who are not suitable for the trial as determined by the investigator;
11. Known alcohol or drug dependence;
12. Mental disorder or poor compliance;
13. Women who are pregnant or lactating;
14. Have received live attenuated vaccine within 4 weeks before the first administration or scheduled to receive during the study period.
15. The Investigator considers that the subject is unsuitable to participate in this study because of any clinical or laboratory test abnormalities or other reasons.
16.A malignant tumor that has been active in the past two years (Except for tumors in this study, cured stage Ib cervical cancer or lower, non-invasive basal cell or squamous cell skin cancer, malignant melanoma with complete response (CR) > for 10 years, and other malignant tumors with complete response (CR) BBB>r 5 years)

Trial locations and contacts

1 site in 1 country.

China1 site

Dragonboat Biopharmaceutical,Co.,Ltd
Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: An Exploratory Clinical Study of Human Anti-PD-L1 Monoclonal Antibody Injection (LDP) Combined With Recombinant Anti-EGFR Human Mouse Chimeric Monoclonal Antibody Injection (CDP1) in Patients With Advanced Malignant Tumor

Read the detailed description

This is an open, dose-escalation and dose-extension exploratory clinical study for patients with advanced malignancy who have failed standard therapy. In the dose-escalation phase, a fixed dose of CDP1 will be given once a week, while LDP will be given every two weeks with dose climbing. Then, cohort studies (cohorts 1 to 5) will be conducted during the dose-expansion phase. The purpose is to preliminarily evaluate the safety and efficacy of LDP combined with CDP1 in the treatment of patients with advanced malignant tumor, and to determine the recommended dose for clinical trial.

Conditions: Advanced Malignant Tumor
Being tested: Human Anti-PD-L1 Monoclonal Antibody Injection (LDP) Combined with Recombinant Anti-EGFR Human Mouse Chimeric Monoclonal Antibody Injection (CDP1)

What participants receive

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

Human Anti-PD-L1 Monoclonal Antibody Injection (LDP) Combined with Recombinant Anti-EGFR Human Mouse Chimeric Monoclonal Antibody Injection (CDP1)Drug
Also called LDP combined with CDP1
In the dose-escalation phase, CDP1 400 mg/ m2 will be given in the first week, then 250 mg/m2 will be given evert week. LDP will be given every two weeks with dose climbing of 5 mg/kg, 10 mg/kg, 20 mg/kg. Dose in the dose-expansion phase according to the assesment in the dose-escalation phase.

Study groups in NCT04739111
Study group	Role	What they receive
Experimental Arms	Experimental	All participants will receive treatment with LDP combined with CDP1. In the dose-escalation phase, a fixed dose of CDP1 will be given once a week, while LDP will be given every two weeks with dose climbing. Then, cohort studies (cohorts 1 to 5) will be conducted during the dose-expansion phase. Receives: Drug: Human Anti-PD-L1 Monoclonal Antibody Injection (LDP) Combined with Recombinant Anti-EGFR Human Mouse Chimeric Monoclonal Antibody Injection (CDP1)

What is being measured

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

Incidence of adverse events
Adverse events (AEs) refer to all adverse medical events that occur when subjects sign the informed consent, which may be manifested as symptoms, signs, diseases or abnormal laboratory tests, but not necessarily causally related to the investigational drug.
Measured: From first dose of LDP combined of CDP1 through 30 days after last dose, up to 5 months.
Dose Limiting Toxicities (DLT)
Number of participants with dose limiting toxicity (DLT)
Measured: Time Frame: 28 days after first dose of LDP combined of CDP1, up to 24 months.
Recommended dose for clinical trials
A comprehensive evaluation of the results from the dose escalation/expansion phase was conducted to determine the recommended dose for the clinical trial.
Measured: up to 24 months

Secondary outcomes (8)

Objective response rate (ORR)
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1
Measured: From first dose of LDP combined of CDP1, up to 2 years.
Duration of response (DOR)
The duration of response (DOR) is defined as the time from the beginning of the first tumor assessment as PR or CR to the first assessment as PD or death from any cause.
Measured: From first dose of LDP combined of CDP1, an average of 6 months.
Disease control rate (DCR)
Disease control rate (DCR) is defined as the proportion of the optimal time response of CR, PR, disease stable (SD) (i.e. CR+PR+SD) between initiation of the trial drug and withdrawal from the trial, as assessed according to RECIST1.1 criteria
Measured: From first dose of LDP combined of CDP1, up to 2 years.
Progression-free survival (PFS)
Progression-free survival (PFS) is defined as the time elapsed from the day the study drug was first administered until the first imaging assessment of disease progression (PD) or death from any cause.
Measured: From first dose of LDP combined of CDP1, an average of 6 months.
Maximum plasma concentrations (Cmax)
Pharmacokinetic parameter, Observed Maximum Serum Concentration (Cmax) of LDP and CDP1.
Measured: an average of 6 months
Area under the plasma concentration-time curve from zero to last concentration time (AUC0-t)
Pharmacokinetic Parameters, Area Under the Serum Concentration-time Curve From Time Zero to the Last Sampling Time (AUC0-t) of LDP and CDP1.
Measured: an average of 6 months
Half-life (t1/2)
Pharmacokinetic parameters,Apparent Terminal Half-life (t1/2) of LDP and CDP1.
Measured: an average of 6 months
anti-drug antibody (ADA)
Anti-drug antibody (ADA) is tested for immunogenicity assessment , titer and neutralizing antibody analysis were performed when ADA was positive, and immunocomplex (CIC) and complement analysis were performed.
Measured: an average of 6 months

Timeline

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

29 Jan 20215 Sep 2022

First posted4 Feb 2021
Study start29 Jan 2021
Primary completion5 Sep 2022
Study completion5 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced Malignant TumorStudies 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: Not applicable
Intervention model: Sequential
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04739111
Sponsor's protocol ID: BCSW-LDP+CDP1-Ⅰ-01
Status last verified: Sep 2022
First submitted: 1 Feb 2021
Last updated: 6 Jul 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Active, not recruitingPhase 1
Advanced or Recurrent Solid Tumors Treated With SHetA2
Solid Tumor, Adult

All Advanced Malignant Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Exploratory Clinical Study of Human Anti-PD-L1 Monoclonal Antibody Injection (LDP) Combined With Recombinant Anti-EGFR Human Mouse Chimeric Monoclonal Antibody Injection (CDP1) in Patients With Advanced Malignant Tumor
ClinicalTrials.gov ID: NCT04739111
Acronym / sponsor ID: BCSW-LDP+CDP1-Ⅰ-01
Conditions: Advanced Malignant Tumor
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Dragonboat Biopharmaceutical Company LimitedIndustry (pharma, biotech, devices)
Collaborators: West China Hospital
Study start: 29 Jan 2021 (actual)
Primary completion: 5 Sep 2022 (actual)
Study completion: 5 Sep 2022 (actual)
First posted: 4 Feb 2021 (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: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Experimental Arms	Experimental	Drug: Human Anti-PD-L1 Monoclonal Antibody Injection (LDP) Combined with Recombinant Anti-EGFR Human Mouse Chimeric Monoclonal Antibody Injection (CDP1)All participants will receive treatment with LDP combined with CDP1. In the dose-escalation phase, a fixed dose of CDP1 will be given once a week, while LDP will be given every two weeks with dose climbing. Then, cohort studies (cohorts 1 to 5) will be conducted during the dose-expansion phase.

Who may qualify

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

Key inclusion criteria (8 listed)

1. Age ≥ 18 (inclusive), no gender limitation;
2. The estimated survival time is more than 3 months.
3. At least one assessable tumor lesion according to RECIST1.1 (in cohort 1, evaluate lesion is accept);
4. ECOG physical strength score 0-2;
5. No serious abnormal blood system, liver function, kidney function or coagulation function: ANC≥1.5×109 / L, PLT≥75×109 / L, Hb≥9g/dL; TBIL≤1.5×ULN, ALT≤2.5×ULN, AST≤2.5×ULN; Cr ≤ 1.5 × ULN, and creatinine clearance ≥ 50 ml /min(according to Croft Gault formula),Urinary protein ≤2+;or 24-hour urinary protein ≤1g; APTT≤ 1.5 ×ULN, PT ≤ 1.5 × ULN, INR ≤ 1.5 × ULN;"

Key exclusion criteria (16 listed)

1. Received radiotherapy, chemotherapy, targeted therapy, endocrine therapy or immunotherapy within 4 weeks before the first administration, or other unlisted clinical trial drug therapy (mitomycin and nitrosourea are 6 weeks from the last administration, oral fluorouracil drugs such as tegiol and capecitabine are at least 2 weeks from the last administration, small molecule targeted drugs are at least 2 weeks or at least interval 5 half-life (Subject to the longer time) from the last administration, and traditional Chinese medicine with antitumor indications are at least 2 weeks from the last administration.
2. Major organ surgery (excluding puncture biopsy) or significant trauma occurred within 4 weeks prior to the first administration.
3. The adverse effects of previous antitumor therapy have not recovered to CTCAE 5.0 ≤grade1 (except for alopecia)
4. Patients with clinical symptoms of brain metastases, spinal cord compression, cancerous meningitis, or other evidence of uncontrolled brain or spinal cord metastases are not suitable for inclusion as judged by the investigator
5. Patients who had previously received PD-1 or PD-L1 inhibitors or anti-EGFR monoclonal antibody or other immune checkpoint inhibitors and failed;

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
Human Anti-PD-L1 Monoclonal Antibody Injection (LDP) Combined with Recombinant Anti-EGFR Human Mouse Chimeric Monoclonal Antibody Injection (CDP1)Also: LDP combined with CDP1In the dose-escalation phase, CDP1 400 mg/ m2 will be given in the first week, then 250 mg/m2 will be given evert week. LDP will be given every two weeks with dose climbing of 5 mg/kg, 10 mg/kg, 20 mg/kg. Dose in the dose-expansion phase according to the assesment in the dose-escalation phase.	Drug	Experimental Arms

Primary outcome

Incidence of adverse events
Time frame: From first dose of LDP combined of CDP1 through 30 days after last dose, up to 5 months.
Adverse events (AEs) refer to all adverse medical events that occur when subjects sign the informed consent, which may be manifested as symptoms, signs, diseases or abnormal laboratory tests, but not necessarily causally related to the investigational drug.
Dose Limiting Toxicities (DLT)
Time frame: Time Frame: 28 days after first dose of LDP combined of CDP1, up to 24 months.
Number of participants with dose limiting toxicity (DLT)
Recommended dose for clinical trials
Time frame: up to 24 months
A comprehensive evaluation of the results from the dose escalation/expansion phase was conducted to determine the recommended dose for the clinical trial.

8 secondary outcomes

Objective response rate (ORR)
Time frame: From first dose of LDP combined of CDP1, up to 2 years.
Duration of response (DOR)
Time frame: From first dose of LDP combined of CDP1, an average of 6 months.
Disease control rate (DCR)
Time frame: From first dose of LDP combined of CDP1, up to 2 years.
Progression-free survival (PFS)
Time frame: From first dose of LDP combined of CDP1, an average of 6 months.
Maximum plasma concentrations (Cmax)
Time frame: an average of 6 months
Area under the plasma concentration-time curve from zero to last concentration time (AUC0-t)
Time frame: an average of 6 months
Half-life (t1/2)
Time frame: an average of 6 months
anti-drug antibody (ADA)
Time frame: an average of 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
Individual participant dataSharing planned: No

Related trials for Advanced Malignant Tumor

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Active, not recruitingPhase 1
Advanced or Recurrent Solid Tumors Treated With SHetA2
Solid Tumor, Adult

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.

Yongsheng Wang study chair

West China Hospital

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

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 16 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: finished, as of the sponsor's last update on 6 Jul 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Incidence of adverse events (time frame: From first dose of LDP combined of CDP1 through 30 days after last dose, up to 5 months.). The study lists 3 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 NCT04739111.

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 6 Jul 2026.