Health TrialsbyHealthPanel

Phase I Clinical Trial of YKYY031 for Injection in Patients With Advanced Solid Tumors

ConditionMalignant Neoplasms
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing Youcare Kechuang Pharmaceutical Technology Co., Ltd.

About this trial

Phase I study of YKYY031 for injection in patients with advanced solid tumors

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female patients aged 18 to 75 years old at the time of signing the informed consent form.

Histologically or cytologically confirmed advanced or metastatic solid tumors that have failed standard therapy and have no effective treatment options, including but not limited to colorectal cancer, pancreatic cancer, etc.

Patients must have human leukocyte antigen (HLA) subtype HLA-A*11:01.

Patients must test positive for at least one of the tumor-specific antigens (TSA) targeted by YKYY031.

Disqualifiers

Allergy to the investigational product (including any excipients). History of severe allergy to any drug, food, or vaccine, such as anaphylactic shock, angioneurotic edema, allergic dyspnea, anaphylactoid purpura, thrombocytopenic purpura, Arthus reaction, etc.

History of other malignancies, except for cured skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, etc., that have not recurred within 5 years prior to screening, as judged by the investigator to be eligible for enrollment.

Symptomatic central nervous system metastasis or meningeal metastasis, or other evidence indicating uncontrolled central nervous system metastasis or meningeal metastasis, as judged by the investigator to be unsuitable for enrollment. Patients with stable brain metastases (no imaging progression within 4 weeks, and not requiring corticosteroid treatment for at least 4 weeks before the first dose of the study drug) may be enrolled.

Congestive heart failure (New York Heart Association [NYHA] class > II)

Trial design

Design model

Single group

Treatments tested in this trial

  • YKYY031 group (the first stage)

    Drug

    Eligible participants selected through screening will be sequentially assigned to dose groups A1 to A6 (in ascending order of dose) according to their enrollment sequence. Each participant will receive a single intramuscular injection of the corresponding dose of YKYY031 for injection.

  • YKYY031 group (the second stage)

    Drug

    Based on the results of the dose-escalation trial, 1-2 dose groups will be selected for the dose-expansion trial of YKYY031 for injection as monotherapy or in combination with other drugs. Eligible participants will be sequentially assigned to dose groups B1 to B2 (in ascending order of dose) according to their enrollment sequence. Each participant will receive a single intramuscular injection of the corresponding dose of YKYY031 for injection.

Treatment groups

76 Participants
are divided into 1 treatment group
Group A: YKYY031 for injectionExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence of Dose-Limiting Toxicity (DLT)

Time frame
DLT assessment: 28 days post-first dose
2

Treatment-Emergent Adverse Events (TEAEs)

Time frame
Safety assessments: from first dose until the 28 days after the last dose
3

Serious Adverse Events (SAEs)

Time frame
Safety assessments: from first dose until the 28 days after the last dose

Secondary outcomes

1

Cmax

Peak plasma concentration

Time frame
Pre-dose to end of treatment + 28 days (sampling at Day1, Day8, Day15, Day22, Day28, then once every three weeks, assessed up to 2 years）
2

AUC

Area under the plasma concentration versus time curve

Time frame
Pre-dose to end of treatment + 28 days (sampling at Day1, Day8, Day15, Day22, Day28, then once every three weeks, assessed up to 2 years）
3

Objective Response Rate (ORR) per RECIST v1.1

Time frame
Every 8 weeks from first dose until disease progression or death (assessed up to 2 years)
4

Disease Control Rate (DCR) per RECIST v1.1

Time frame
Every 8 weeks from first dose until disease progression or death (assessed up to 2 years)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Youcare Kechuang Pharmaceutical Technology Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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