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NeoplasmsPhase 1NCT04146610

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

A Phase 1 study testing an antibody drug conjugate in people with Neoplasms, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Neoplasms
What is being tested?
an antibody drug conjugate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
Nov 2019to Jun 2021
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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).

Who cannot join

  • 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；
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Cancer Hospital

    Shanghai

Other trials in China

About this study

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

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.

Read the 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.

Conditions
Neoplasms
Being tested
an antibody drug conjugate
Medical subject headings
Neoplasms

What participants receive

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

  • an antibody drug conjugateDrug

    Also called ADC

    Multiple dose grouping

Study groups in NCT04146610
Study groupRoleWhat they receive
Dp303cExperimentalMultiple dose grouping
Receives: Drug: an antibody drug conjugate

What is being measured

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

  1. Maximal Tolerance Dose (MTD) of Dp303c

    The dose level in which >= 2 out of 6 patients have dose-limiting toxicity (DLT). The MTD is defined as the previous dose level.

    Measured: The first treatment cycle 21 days

Secondary outcomes (6)

  1. Maximum concentration (Cmax) of DP303c

    The pharmacokinetics(PK) profile of DP303c

    Measured: approximately 2 years

  2. Time of peak plasma concentration (Tmax)

    The pharmacokinetics(PK) profile of DP303c

    Measured: approximately 2 years

  3. Area under the plasma concentration time curve (AUC) of DP303c

    The pharmacokinetics(PK) profile of DP303c

    Measured: approximately 2 years

  4. Overall response rate (ORR)

    To preliminarily evaluate ORR in patients with advanced solid tumors.

    Measured: approximately 2 years

  5. Duration of Response (DoR)

    To preliminarily evaluate DoR in patients with advanced solid tumors.

    Measured: approximately 2 years

  6. Immunogenicity (anti-drug antibody ADA)

    Percentage of subjects producing detectable anti-drug antibodies (ADA)

    Measured: approximately 2 years

Timeline

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

  1. First posted31 Oct 2019
  2. Study startNov 2019 (estimated)
  3. Primary completionJun 2021 (estimated)
  4. Study completionJun 2021 (estimated)

Resources

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
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04146610
Sponsor's protocol ID
DP303c201801
Status last verified
Oct 2019
First submitted
28 Oct 2019
Last updated
31 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhang J, Du Y, Meng Y, Liu X, Mu Y, Liu Y, Shi Y, Wang J, Zang A, Gu S, Liu T, Zhou H, Guo H, Xiang S, Zhang X, Wu S, Qi H, Li M, Hu X. First-in-human study of DP303c, a HER2-targeted antibody-drug conjugate in patients with HER2 positive solid tumors. NPJ Precis Oncol. 2024 Sep 12;8(1):200. doi: 10.1038/s41698-024-00687-7.

    PubMed 39266619

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing an antibody drug conjugate in people with Neoplasms, run by CSPC ZhongQi Pharmaceutical Technology 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 18 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: status not confirmed, as of the sponsor's last update on 31 Oct 2019. 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?

Results are not available in the source record.

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?

Maximal Tolerance Dose (MTD) of Dp303c (time frame: The first treatment cycle 21 days). 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 NCT04146610, which also lists 1 linked publication.

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 31 Oct 2019.

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