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Localized Advanced or Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction AdenocarcinomaPhase 1/2NCT06577376

A PhaseⅠ/Ⅱ Study of Simmitinib or Irinotecan Liposomes Combined With DP303c in Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma

A Phase 1/2 study testing DP303c, Simmitinib tablets and Irinotecan liposomes in people with Localized Advanced or Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma and Expressing Human Epidermal Growth Factor Receptor-2 (HER-2), run by Shanghai Runshi Pharmaceutical Technology Co., Ltd.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

This study is divided into two parts: Cohort 1 and Cohort 2. Cohort 1 includes the dose escalation phase of DP303c combined with simmitinib, as well as the randomized controlled trial (RCT) phase of DP303c combined with simmitinib; Cohort 2 includes dose escalation/dose extension of DP303c combined with irinotecan… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
DP303c, Simmitinib tablets and Irinotecan liposomes
Could I receive a placebo?
No, everyone receives an active treatment
How many people
252 participants
Where
No sites listed yet
Study dates
26 Aug 2024to 26 Aug 2027
Phase
Phase 1/2
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

  • 1. Aged 18-75 (including) years old; 2. Gastric adenocarcinoma or gastroesophageal junction adenocarcinoma diagnosed by histology or cytology; 3. Disease progression after receiving one or two lines of systemic treatment in the past (first-line treatment must be platinum/fluorouracil combination chemotherapy with or without immune checkpoint inhibitors); 4. There should be at least one measurable lesion according to the response evaluation criteria in solid tumors (RECIST v1.1),; 5. HER2 expression status: 2+ to 3+(applicable to Cohort 1) or 1+(applicable to Cohort 2); 6. Adequate organ or bone marrow function
  • Aged 18-75 (including) years old;
  • Gastric adenocarcinoma or gastroesophageal junction adenocarcinoma diagnosed by histology or cytology;
  • Disease progression after receiving one or two lines of systemic treatment in the past (first-line treatment must be platinum/fluorouracil combination chemotherapy with or without immune checkpoint inhibitors);
  • There should be at least one measurable lesion according to the response evaluation criteria in solid tumors (RECIST v1.1),;
  • HER2 expression status: 2+ to 3+(applicable to Cohort 1) or 1+(applicable to Cohort 2);
  • Adequate organ or bone marrow function

Who cannot join

  • *Eligibility Criteria:
  • Patients who have experienced toxicity during previous treatment with trastuzumab or trastuzumab biosimilars, resulting in permanent discontinuation of trastuzumab or trastuzumab biosimilars;
  • Patients with a history of allergies to any component of DP303c and deemed severe by the researchers
  • There is uncontrolled serosal fluid accumulation that requires frequent drainage or medical intervention;
  • Active leptomeningeal disease or uncontrolled CNS metastasis;
  • Has a history of serious cardiovascular and cerebrovascular diseases;
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  • There was a peripheral neuropathy of grade ≥ 2 (refer to NCI CTCAE 5.0) prior to enrollment;
  • History of gastrointestinal perforation and/or fistula within 6 months of first use of medication;
  • Inability to swallow medication orally or presence of clinically significant gastrointestinal diseases;
  • Urine protein ≥++ and 24-hour urine protein quantification>1.0 g during screening period;
  • There are eye diseases that require intervention, such as corneal diseases, retinal diseases, or active eye infections;
  • Used CYP3A4 strong inhibitors or CYP3A4 strong inducers 14 days before the first medication ;
  • Used UGT1A1 strong inhibitor before first medication and wash-off period is less than 5 half-lives.

About this study

Official title: A Multicenter, Open-label Phase I/II Clinical Study to Evaluate the Safety and Efficacy of Simmitinib or Irinotecan Liposomes Combined With DP303c Injection in the Treatment of HER2 Expressing Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma

This study is divided into two parts: Cohort 1 and Cohort 2. Cohort 1 includes the dose escalation phase of DP303c combined with simmitinib, as well as the randomized controlled trial (RCT) phase of DP303c combined with simmitinib; Cohort 2 includes dose escalation/dose extension of DP303c combined with irinotecan liposomes, as well as RCT stage of DP303c combined with irinotecan liposomes.

Being tested
DP303c, Simmitinib tablets, Irinotecan liposomes, Paclitaxel or docetaxel or irinotecan

What participants receive

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

  • DP303cDrug

    DP303c is an antibody conjugate drug (ADC), composed of one anti-HER2 monoclonal antibody coupled to one MMAE via an enzyme specific linker

  • Simmitinib tabletsDrug

    A novel small molecule inhibitor targeting fibroblast growth factor receptor (FGFR), vascular endothelial growth factor receptor (VEGFR2, KDR), and colony-stimulating factor 1 receptor (CSF-1R)

  • Irinotecan liposomesDrug

    A chemotherapy

  • Paclitaxel or docetaxel or irinotecanDrug

    Paclitaxel or docetaxel or irinotecan is used as a control.

Study groups in NCT06577376
Study groupRoleWhat they receive
DP303c injection, dose level 1, Q3W + simmitinib tablets, dose level 1, D1-D21, Q4WExperimentalDP303c injection, dose level 1, intravenous drip, Q3W + simmitinib tablets, dose level 1, oral, QD, taken for 3 weeks, discontinued for 1 week, Q4W
Receives: Drug: DP303c; Drug: Simmitinib tablets
DP303c injection, dose level 1, Q3W + simmitinib tablets, dose level 2, D1-D21, Q4WExperimentalDP303c injection, dose level 1, intravenous drip, Q3W + simmitinib tablets, dose level 2, oral, QD, taken for 3 weeks, discontinued for 1 week, Q4W
Receives: Drug: DP303c; Drug: Simmitinib tablets
DP303c injection, dose level 1, Q2W + simmitinib tablets, dose level 2, D1-D21, Q4WExperimentalDP303c injection, dose level 1, intravenous drip, Q2W + simmitinib tablets, dose level 2, oral, QD, taken for 3 weeks, discontinued for 1 week, Q4W
Receives: Drug: DP303c; Drug: Simmitinib tablets
DP303c injection, dose level 2, Q3W + simmitinib tablets, dose level 2, D1-D21, Q4WExperimentalDP303c injection, dose level 2, intravenous drip, Q3W + simmitinib tablets, dose level 2, oral, QD, taken for 3 weeks, discontinued for 1 week, Q4W
Receives: Drug: DP303c; Drug: Simmitinib tablets
DP303c RP2D + irinotecan liposomes RP2DExperimentalNot described
Receives: Drug: DP303c; Drug: Irinotecan liposomes
Single agent chemotherapy chosen by researchersActive comparatorSingle agent chemotherapy chosen by researchers: paclitaxel, docetaxel, or irinotecan
Receives: Drug: Paclitaxel or docetaxel or irinotecan

What is being measured

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

  1. Dose-limiting toxicity(DLT) occurrence and incidence

    Measured: Up to approximately 36 months after the first participant is enrolled

  2. Adverse events (AE) occurrence and incidence

    Measured: Up to approximately 36 months after the first participant is enrolled

  3. Objective response rate (ORR) per RECIST 1.1

    Measured: Up to approximately 36 months after the first participant is enrolled

  4. Serious adverse events (SAE) occurrence and incidence

    Measured: Up to approximately 36 months after the first participant is enrolled

Secondary outcomes (9)

  1. Disease control rate (DCR) per RECIST 1.1

    Measured: Up to approximately 36 months after the first participant is enrolled

  2. Duration of response (DoR) per RECIST 1.1

    Measured: Up to approximately 36 months after the first participant is enrolled

  3. Progression free survival (PFS) per RECIST 1.1

    Measured: Up to approximately 36 months after the first participant is enrolled

  4. Overall survival(OS)

    Measured: Up to approximately 36 months after the first participant is enrolled

  5. Blood drug concentration of DP303c

    Measured: Up to approximately 36 months after the first participant is enrolled

  6. Blood concentration of total anti-DP303c antibody

    Measured: Up to approximately 36 months after the first participant is enrolled

  7. Positive incidence of anti-DP303c antibody (ADA)

    Measured: Up to approximately 36 months after the first participant is enrolled

  8. HER2 expression level

    Measured: Up to approximately 36 months after the first participant is enrolled

  9. Blood concentration of simmitinib

    Measured: Up to approximately 36 months after the first participant is enrolled

Timeline

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

  1. First posted29 Aug 2024
  2. Study start26 Aug 2024 (estimated)
  3. Primary completion26 Aug 2026 (estimated)
  4. Study completion26 Aug 2027 (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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
In the dose escalation phase, a "3+3" approach is used to explore the safety and tolerability of subjects, and in the randomized controlled phase, the efficacy of different combination doses is explored
Masking
None (open label)
Enrolment
252 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06577376
Sponsor's protocol ID
SYSA1501-010
Status last verified
Aug 2024
First submitted
21 Aug 2024
Last updated
5 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing DP303c, Simmitinib tablets and Irinotecan liposomes in people with Localized Advanced or Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma and Expressing Human Epidermal Growth Factor Receptor-2 (HER-2), run by Shanghai Runshi Pharmaceutical Technology Co., Ltd.

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 7 inclusion and 13 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: opening soon, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Dose-limiting toxicity(DLT) occurrence and incidence (time frame: Up to approximately 36 months after the first participant is enrolled). The study lists 4 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 NCT06577376.

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 5 Sep 2024.

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