---
title: Clinical Trial of HRS-4642 Plus SHR-A2102 in Patients With Advanced Solid Tumors
nct_id: NCT06955390
overall_status: NOT_YET_RECRUITING
phase: PHASE1, PHASE2
sponsor: Henan Cancer Hospital
study_type: INTERVENTIONAL
primary_condition: Solid Tumors
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06955390.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06955390"
ct_last_update_post_date: 2025-05-02
last_seen_at: "2026-05-12T06:05:42.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Clinical Trial of HRS-4642 Plus SHR-A2102 in Patients With Advanced Solid Tumors

**Official Title:** An Exploratory Clinical Study of HRS-4642 in Combination With SHR-A2102 for the Treatment of Advanced Solid Tumors

**NCT ID:** [NCT06955390](https://clinicaltrials.gov/study/NCT06955390)

## Key Facts

- **Status:** NOT_YET_RECRUITING
- **Phase:** PHASE1, PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 32
- **Lead Sponsor:** Henan Cancer Hospital
- **Conditions:** Solid Tumors
- **Start Date:** 2025-05-01
- **Completion Date:** 2026-12-01
- **CT.gov Last Update:** 2025-05-02

## Brief Summary

The purpose of this study is to observe and evaluate the efficacy and safety of HRS-4642 combined with SHR-A2102 in the treatment of advanced solid tumors

## Detailed Description

This study is a prospective, single-arm, exploratory clinical trial. It plans to enroll patients with advanced solid tumors , treating them with HRS-4642 in combination with SHR-A2102. The entire study is divided into two stages: a safety run-in period and an efficacy exploration period.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

1. Have the ability to give informed consent, have signed informed and able to comply with the treatment plan to visit the tests and other procedural requirements
2. The age of signing the informed consent is from 18 to 75 years old, regardless of gender
3. Subjects with pathologically confirmed locally advanced unresectable or metastatic solid tumors
4. The ECOG score is 0 or 1
5. Expected survival ≥12 weeks
6. At least one measurable lesion according to RECIST v1.1 criteria
7. Good level of organ function
8. Male subjects whose partners are women of childbearing age and female subjects who are fertile are required to use highly effective contraceptive methods

Exclusion Criteria:

1. subjects with uncontrolled or active brain metastasis；
2. subjects with clinical significant lung disease;
3. subjects with history of autoimmune diseases;
4. Known active hepatitis B or C infection;
5. Subjects with severe cardiovascular and cerebrovascular diseases
6. Uncontrolled tumor-related pain
7. Severe infections that require intravenous antibiotic, antiviral or antifungal control
8. Clinically symptomatic moderate to severe ascites; Uncontrollable or moderate or above pleural effusion, pericardial effusion
9. Received anti-tumor therapy 4 weeks prior to initiation of study treatment.
10. Known allergic to any compound of SHR-A2102 or HRS-4642
11. Other serious accompanying illnesses, which, in the investigator's assessment, could seriously adversely affect the safety of the treatment
```

## Arms

- **Treatment group** (EXPERIMENTAL) — SHR-A2102+HRS-4642

## Interventions

- **SHR-A2102+HRS-4642** (DRUG) — A fixed dose was used for SHR-A2102,HRS-4642 can be dose adjusted.

## Primary Outcomes

- **Dose Limited Toxicity(DLT)** _(time frame: At the end of Cycle 1 (each cycle is 14 days))_ — one or more unacceptable toxic reactions that occur after administration, leading to an inability to further increase the dose or extend the dosing cycle.
- **Objective Response Rate (ORR)** _(time frame: up to 1 year)_ — the proportion of patients with a confirmed complete response or partial response on two consecutive occasions≥4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

## Secondary Outcomes

- **Progression-free Survival (PFS)** _(time frame: up to 2 year)_
- **Overall survival(OS)** _(time frame: up to 2 year)_
- **Disease Control Rate (DCR)** _(time frame: up to 1 year)_
- **Duration of response (DoR)** _(time frame: up to 1 year)_
- **Incidence and severity of adverse events (AE) and serious adverse events (SAE) and laboratory** _(time frame: Begin from sign the ICF until the end of the safety follow-up period，Up to approximately 2 years.)_

## Locations (1)

- Henan Cancer Hospital, Zhengzhou, Henan, China

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.henan cancer hospital|zhengzhou|henan|china` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT06955390*  
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