Health Trials

A Phase I Study of SIM0505 in Participants With Advanced Solid Tumors

ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNextCure, Inc.

About this trial

This is an open-label, multicenter phase 1 study to evaluate the safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0505 in Adult Participants with Advanced Solid Tumors

Eligibility criteria

Qualifiers

Written informed consent is obtained prior to any procedures that are not considered standard of care

≥18 years of age.

Participants with histologically or cytologically confirmed advanced solid tumors, who have failed or are ineligible for standard of care therapies.

Have progressed on at least one prior systematic anti-tumor regimen, and presence of at least one evaluable lesion according to RECIST Version 1.1. Measurable lesions are required in the backfill period.

Disqualifiers

For Part 2: has clear cell, mucinous or sarcomatous histology, mixed tumors containing any histology, or low-grade/borderline ovarian cancer; mixed nonsmall cell and small cell carcinoma, or adenosquamous cell lung cancer with an adenocarcinoma component <50% (the participant is eligible if the adenocarcinoma component is ≥50%).

Any other malignancy within 2 years prior to the first dose of the study treatment except for localized cancers that are considered to have been cured and in the opinion of the Investigator present a low risk for recurrence.

Participant has symptomatic central nervous system (CNS) metastases, or CNS metastases requiring CNS-directed local therapy (such as radiotherapy or surgery) or corticosteroids therapy within 2 weeks of first dose of study treatment.

History of bowel obstruction within 3 months prior to the first dose of study treatment.

Trial design

Treatments tested in this trial

  • SIM0505 for injection
  • SIM0505 for injection

Treatment groups

414 Participants
are divided into 5 treatment groups

Sponsors and collaborators

NextCure, Inc.

Lead sponsor

Shanghai Xianxiang Medical Technology Co., Ltd.

Collaborator

Source ClinicalTrials.gov