Platinum Resistant Ovarian Cancer / SIM0505 for injection / Advanced Solid Tumors · Phase 1 Trial

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

ClinicalTrials.gov · August 17, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a clinical trial registry record for an ongoing Phase 1 study of SIM0505, an investigational drug for advanced solid tumors. No efficacy or safety results have been posted to the registry; the study is currently recruiting participants. This record documents the planned study design and endpoints only, and carries no evidence of clinical benefit or harm.

What was studied

Phase 1, Interventional, Randomized, Sequential, Open label, Treatment purpose. Advanced Solid Tumors, Platinum Resistant Ovarian Cancer, Fallopian Tube Cancer, Renal Cell Carcinoma (RCC), Papillary Renal Cell Carcinoma (Prcc), Uterine Ser…; age from 18 Years. Intervention: SIM0505 mono dose escalation; SIM0505 mono dose optimization - PROC; SIM0505 mono dose optimization - RCC; SIM0505 mono dose optimization - USC; SIM0505 mono dose optimization - NSCLC. n = 738. 17 sites: United States, China.

Key findings

Safety

Open-label design with no comparator arm; no efficacy or safety data available for assessment.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a Phase 1 trial registration with no reported results; the study is actively recruiting and designed to evaluate safety, tolerability, and preliminary antitumor activity in an early-stage drug development program.

Study design

As stated by the source record.

MethodsPrimary outcome measures: dose escalation: Dose-limiting toxicity (DLT) (assessed at At the end of Cycle 1 (each cycle is 21 days)); dose escalation & optimization: Adverse events (AEs) (assessed at the whole dose escalation phase，an average of 2 year); dose optimization：Objective response rate (ORR) (assessed at the whole dose optimization phase，an average of 1.5 year)

DesignPhase 1, Interventional, Randomized, Sequential, Open label, Treatment purpose

PopulationAdvanced Solid Tumors, Platinum Resistant Ovarian Cancer, Fallopian Tube Cancer, Renal Cell Carcinoma (RCC), Papillary Renal Cell Carcinoma (Prcc), Uterine Ser…; age from 18 Years

Sample size738

InterventionSIM0505 mono dose escalation; SIM0505 mono dose optimization - PROC; SIM0505 mono dose optimization - RCC; SIM0505 mono dose optimization - USC; SIM0505 mono dose optimization - NSCLC

Setting17 sites: United States, China

Reported figures

Quoted from the source exactly as published.

PhasePhase 1

Estimated enrollment738

Primary outcome measure (dose escalation phase)Dose-limiting toxicity (DLT) at end of Cycle 1 (21 days)

Primary outcome measure (dose escalation & optimization phase)Adverse events (AEs), average 2 years

Primary outcome measure (dose optimization phase)Objective response rate (ORR), average 1.5 years

Caveats

This is a registry record; no clinical trial results are posted or reported.
Study is actively recruiting; data collection is ongoing.
Open-label design with no comparator arm; no efficacy or safety data available for assessment.
Planned endpoints include surrogate outcomes (ORR); hard clinical outcomes not specified.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Open-label, multicenter Phase 1 dose escalation and optimization design appropriate for early development.

Directness

moderate

Studies safety and preliminary efficacy in target populations with advanced solid tumors; open-label limits directness.

Consistency

insufficient

Registry record only; no results reported yet, therefore consistency cannot be assessed.

Risk of bias

limited

Open-label design without comparator; blinding not stated; early-phase toxicity assessments are objective but subject to observation bias.

Sample adequacy

insufficient

Estimated enrollment 738 stated but trial is actively recruiting; no results reported to determine statistical power.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT06792552). This is a study registration, not published results. Lead sponsor: NextCure, Inc.. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 738 participants (ESTIMATED). Conditions: Advanced Solid Tumors, Platinum Resistant Ovarian Cancer, Fallopian Tube Cancer, Renal Cell Carcinoma (RCC), Papillary Renal Cell Carcinoma (Prcc), Uterine Serous Carcinoma (USC), NSCLC (Non-small Cell Lung Cancer), Primary Peritoneal Cancer. Interventions: DRUG: SIM0505 for injection; DRUG: SIM0505 for injection. Primary outcome measures: dose escalation: Dose-limiting toxicity (DLT) , At the end of Cycle 1 (each cycle is 21 days); dose escalation & optimization: Adverse events (AEs) , the whole dose escalation phase，an average of 2 year; dose optimization：Objective response rate (ORR) , the whole dose optimization phase，an average of 1.5 year. Brief summary: 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

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

NextCurePlatinum Resistant Ovarian CancerSIM0505 for injectionAdvanced Solid TumorsFallopian Tube CancerNCT06792552