Double antibody attack: early trial combines immune and Growth-Signal blockers against advanced cancers
NCT ID NCT04739111
First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time
Summary
This early-stage trial is testing a combination of two lab-made antibodies in people with advanced solid tumors that have not responded to standard treatments. One antibody (LDP) aims to reactivate the immune system against cancer, while the other (CDP1) blocks a growth signal on cancer cells. The main goals are to evaluate safety, identify side effects, and determine the best dose for future studies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- LDP (anti-PD-L1 antibody) combined with CDP1 (anti-EGFR antibody)
- What this could lead to
- If safe and effective, this combination could offer a new treatment option for people with advanced cancers that have not responded to other therapies.
- What could go wrong
- This is a very early (Phase 1) trial with only 12 participants, so it is primarily testing safety and dosing. The combination may not shrink tumors or may cause significant side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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12 people
The number who actually took part.
- Started
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Jan 2021
- Finished
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Sep 2022
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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). Exclusion Criteria: * 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; * 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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Dragonboat Biopharmaceutical,Co.,Ltd
Shanghai, Shanghai Municipality, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Neoadjuvant low-dose radiotherapy, tislelizumab, combined with albumin-bound paclitaxel and cisplatin in resectable locally advanced head and neck squamous cell carcinoma (NeoRTPC02): an open label, single-arm, phase II clinical trial
- Ivosidenib plus mFOLFOXIRI and celecoxib as a treatment for BRAF-targeted therapy-refractory BRAF V600E-mutant colorectal cancer patients: a phase II study
- Operationalising multifactorial ovarian cancer risk assessment using the CanRisk tool versus standard practices.
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