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Study of DP303c Administered Intravenously to Subjects With HER2-Positive in Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04146610
Recruitment Status : Not yet recruiting
First Posted : October 31, 2019
Last Update Posted : October 31, 2019
Information provided by (Responsible Party):
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Brief Summary:
A phase Ia, multicenter, open and dose-increasing study of DP303c to evaluate the safety , pharmacokinetics, immunogenicity and antitumor activity of subjects with HER2-positive advanced solid tumors.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: an antibody drug conjugate Phase 1

Detailed Description:
Dose escalation study: Primary purpose: To investigate the safety and tolerability of DP303c in subjects with HER2-positive advanced solid tumors . Secondary purpose:1. To characterize the pharmacokinetics(PK) profile of DP303c;2. To assess the preliminary anti tumor activity of DP303c; 3. To characterize immunogenicity of DP303c.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ia, Multicenter, Open and Dose-increasing Study of DP303c to Evaluate the Safety , Pharmacokinetics, Immunogenicity and Antitumor Activity of Subjects With HER2-Positive Advanced Solid Tumors
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Arm Intervention/treatment
Experimental: Dp303c
Multiple dose grouping
Drug: an antibody drug conjugate
Multiple dose grouping
Other Name: ADC

Primary Outcome Measures :
  1. Maximal Tolerance Dose (MTD) of Dp303c [ Time Frame: The first treatment cycle 21 days ]
    The dose level in which >= 2 out of 6 patients have dose-limiting toxicity (DLT). The MTD is defined as the previous dose level.

Secondary Outcome Measures :
  1. Maximum concentration (Cmax) of DP303c [ Time Frame: approximately 2 years ]
    The pharmacokinetics(PK) profile of DP303c

  2. Time of peak plasma concentration (Tmax) [ Time Frame: approximately 2 years ]
    The pharmacokinetics(PK) profile of DP303c

  3. Area under the plasma concentration time curve (AUC) of DP303c [ Time Frame: approximately 2 years ]
    The pharmacokinetics(PK) profile of DP303c

  4. Overall response rate (ORR) [ Time Frame: approximately 2 years ]
    To preliminarily evaluate ORR in patients with advanced solid tumors.

  5. Duration of Response (DoR) [ Time Frame: approximately 2 years ]
    To preliminarily evaluate DoR in patients with advanced solid tumors.

  6. Immunogenicity (anti-drug antibody ADA) [ Time Frame: approximately 2 years ]
    Percentage of subjects producing detectable anti-drug antibodies (ADA)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Voluntary agreement to provide written informed consent;
  • Aged 18 to 75 years, both male and female;
  • Patients with advanced solid tumors diagnosed by histology and / or cytology, confirmed to be HER2 positive by pathological examination, unable to accept or have no standard treatment, failure of standard treatment (disease progress or treatment without remission after treatment) or intolerable patients; HER2-positive is defined as IHC 2+ and ISH positive or IHC 3+; IHC scores of breast cancer and gastric cancer are based on their respective standards, while IHC scores of other cancers are based on the scoring standards of breast cancer;
  • The ECOG performance status is 0 to 1,and the expected survival time is more than 3 months;
  • Subjects must have laboratory values within the limits described below:

ANC ≥1.5 x 109/L Platelet count ≥100 x 109/L Hemoglobin ≥9 g/dL Serum creatinine within normal limits OR creatinine clearance ≥60 mL/minute Serum total bilirubin ≤1.5 x ULN (up to 3 x ULN in subjects with Gilbert's syndrome) AST (SGOT) and ALT (SGPT) ≤2.5 x ULN (OR ≤5 X ULN for subjects with liver metastases) PT/INR and APTT ≤1.5 x ULN

  • According to the RECIST v1.1 standard, there must be a measurable lesion at the base line;
  • WOCBP must have a negative pregnancy test prior to study entry;
  • WOCBP and male subjects must agree to use adequate contraception from study entry through at least 12 weeks after the last dose of study drug (see Appendix 5);
  • A washout period is required for subjects who have recently received systemic antitumor therapy. The period prior to the subject's planned first dose of DP303c must be either at least 28 days or 5 half-lives, whichever is shorter. Antitumor therapy includes chemotherapy, immunotherapy, targeted therapy, endocrine therapy, radiotherapy (except local radiotherapy for pain relief, 14 days after treatment).

Exclusion Criteria:

  • Pregnant or breastfeeding women;
  • Refusal to use effective methods of contraception (see inclusion criteria for details);
  • Not recovered from AEs caused by previous drugs or radiotherapy (reference NCI CTCAE 5.0, ≤Grade 1 or at baseline), with the exception of alopecia;
  • History of cardiac dysfunction with LVEF <40% while on trastuzumab therapy;
  • Subjects with a history of allergy to any components(tratozumab analogues, MMAE, sodium citrate dihydrate, citrate monohydrate, polysorbitol 20 and sucrose, etc.) of DP303cand those who researchers consider to be more serious;
  • A history of central nervous system (CNS) metastases or epilepsy, asymptomatic or stable, and not requiring treatment at least 4 weeks before study therapy began;
  • Active lung infection or pneumonitis or a history of non-infectious interstitial lung disease;
  • Requires supplemental oxygen;
  • History of congestive heart failure, unstable angina pectoris, unstable atrial fibrillation, or cardiac arrhythmia. Subjects who have the following types of cardiac impairment at the time of enrollment:

New York Heart Association class III or IV heart disease Uncontrolled angina, congestive heart failure, or myocardial infarction within 6 months prior to enrolment An LVEF by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan <50% or below the lower limit of normal for the institution QT interval prolongation (>450 ms in males, >470 ms in females),QT interval correction (QTcF) was corrected by Fridericia formula

  • In the first 90 daysof the study, Cumulative anthracycline dose ≥360 mg/m2 doxorubicin or equivalent;
  • Peripheral neuropathy ≥Grade 2 or greater (NCI CTCAE v 5.0);
  • 12.Non-manageable electrolyte imbalances including hypokalemia, hypocalcemia, or hypomagnesemia (≥Grade 2 or greater based on NCI CTCAE v 5.0);
  • Any uncontrollable intercurrent illness, infection, or other conditions that could limit study compliance or interfere with assessments;
  • Serologic status reflecting active hepatitis B or C infection;
  • Subjects with immunodeficiency, including HIV positive;
  • Patients were treated with CYP3A inhibitors within 14 days of the first dose (drugs that increased specific CYP substrate AUC ≥ 5 times, such as Mibefradil, verapamil, diltiazem, nefazodone, clarithromycin, Telithromycin, Troleandomycin, Erythromycin, fluconazole, itraconazole, ketoconazole, Posaconazole,VoriconazoleTablets,Elvitegravir,indinavir,lopinavir, Nelfinavir,Ritonavir,Saquinavir, Boceprevir,Incivo,telaprevir,Conivaptan,idelalisib) or strong CYP3A inducers (Avasimibe, phenobarbital, phenytoin, carbamazepine,Rifampicin, rifabutin,enzalutamide, mitotane, Hypericum perforatum );
  • Other serious or uncontrollable diseases or conditions that may affect the assessment of the primary endpoint or that the investigator considers to be at risk for participants participating in this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04146610

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Fudan University Cancer Hospital
Shanghai, China
Sponsors and Collaborators
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
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Responsible Party: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. Identifier: NCT04146610    
Other Study ID Numbers: DP303c201801
First Posted: October 31, 2019    Key Record Dates
Last Update Posted: October 31, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Immunologic Factors
Physiological Effects of Drugs