Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of LM-108 ± Penpulimab+Chemotherapy in Advanced Solid Tumors - Cohort C

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.

About this trial

This trial is the cohort C part of a multicenter, open label Phase Ib/II clinical study evaluating the preliminary efficacy, safety, and tolerability of LM-108 combined with anti-tumor therapy in patients with advanced solid tumors. The dose of LM-108 combined with penpulimab, albumin paclitaxel, and gemcitabine is recommended in Phase Ib.Explore the efficacy and safety of LM-108 combined with anti-tumor therapy in patients with advanced pancreatic cancer in Phase II.

Eligibility criteria

Qualifiers

Age 18 or above.

The Eastern Cooperative Oncology Group (ECOG) physical fitness status score is 0-1 points.

There should be at least one measurable lesion.

All acute toxic reactions caused by previous anti-tumor treatments or surgical procedures have been relieved to grade 0-1 or to the levels specified in the inclusion/

Disqualifiers

Have sufficient organ and bone marrow function

Expected survival period ≥ 12 weeks

Infertility is defined as women who have reached menopause or have undergone bilateral oophorectomy with medical records. Male participants and female participants with fertility must agree to use one medically approved contraceptive measure during the trial period and within 6 months after the last administration of the trial drug or within 9 months after the last administration of chemotherapy drug (oxaliplatin) (whichever is later). The serum pregnancy test must be negative within 3 days before starting the study medication and not during lactation.

With my consent and signed informed consent form.

Trial design

Treatments tested in this trial

  • LM-108 injection
  • Penpulimab injection
  • Paclitaxel for injection (albumin bound)
  • Gemcitabine hydrochloride for injection

Treatment groups

72 Participants
are divided into 2 treatment groups