A Clinical Trial of SIBP-A19 Injection in the Treatment of Advanced Malignant Solid Tumor Patients

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Institute Of Biological Products

About this trial

To evaluate the safety, tolerability, and pharmacokinetic characteristics of SIBP-A19 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D).

Eligibility criteria

Qualifiers

Age range from 18 to 75 years old (including boundary values), regardless of gender.

Voluntarily participate in this study and sign the informed consent form.

Participants with advanced or metastatic solid tumors diagnosed by histology or cytology, without standard treatment, standard treatment failure, or intolerance.

Willing and able to provide sufficient fresh collected or archived tumor tissue samples or provide testing reports from legitimate institutions that meet the requirements.

Disqualifiers

The participant has had other malignant tumors that have not been cured within the past 5 years (excluding malignant tumors that have been clearly cured, such as thyroid cancer, cured basal cell carcinoma of the skin, and cervical carcinoma in situ).

The participant has untreated imaging confirmed central nervous system metastasis.

Meningeal metastases.

Patients with brain metastases who have received systematic or curative brain metastasis treatment (radiotherapy or surgery) in the past, have been confirmed stable by imaging for at least 4 weeks, and have stopped systemic hormone, antiepileptic, convulsive drugs, and other treatments for more than 2 weeks without clinical symptoms can be enrolled.

Trial design

Treatments tested in this trial

  • SIBP-A19

Treatment groups

156 Participants
are divided into 1 treatment group