HP007 Monotherapy for Relapsed or Refractory Advanced Solid Tumors

NCT07800936 | Recruiting Phase 1 DMC

• 1 other identifier: HP007CH101
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an open-label, dose-escalation and expansion, Phase I clinical study to evaluate the safety, tolerability, PK characteristics and preliminary antitumor activity of HP007 monotherapy in patients with advanced malignant solid tumors.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (5)

• DLT

  Safety endpoints: incidence and severity of DLT

  up to one year

• AE

  Safety endpoints: incidence and severity of adverse events (AE); Abnormal changes in laboratory and other tests with clinical significance

  up to two years

• SAE

  Safety endpoints: incidence and severity of serious adverse events (SAE); Abnormal changes in laboratory and other tests with clinical significance

  up to two years

• MTD

  Maximum tolerated dose (MTD)

  up to one year

• RP2D

  Recommended dose for phase II trial

  up to one year

Secondary Outcomes (20)

• ORR

  up to two years

• DOR

  up to two years

• DCR

  up to two years

• PFS

  up to two years

• OS

  up to two years

Study Arms (1)

HP007

EXPERIMENTAL

Participate will recepit HP007 monotherpy with 4 dose groups

Drug: HP007

Interventions

HP007 DRUG

Participate will recepit HP007 monotherpy with 4 dose groups

HP007

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male/female, 18-75 years inclusive.
• Histologically-confirmed unresectable advanced tumors (breast cancer, HNSCC, cutaneous melanoma, prostate cancer, HCC, etc.);
• no effective standard therapy or disease relapse/metastasis post-standard-of-care.
• ECOG PS 0-1;
• expected survival ≥3 months.
• At least 1 measurable lesion by RECIST 1.1. Lesion in prior radiation field must have confirmed progression ≥4 weeks post-radiation. Prostate cancer subjects must meet PCWG3 progression criteria.
• At least one lesion suitable for repeated intratumoral injection.
• Adequate hematopoietic and organ function:
• Males and females of child-bearing potential agree effective contraception from ICF signature to 3 months after last dose.
• Voluntarily sign ICF and comply with study procedures.

You may not qualify if:

• Past/current medical conditions
• CNS or leptomeningeal metastasis.
• Residual toxicity from prior anti-tumor therapy \>Grade 1 (CTCAE 6.0), except alopecia and Grade 2 peripheral neuropathy without safety risk.
• Poorly controlled pleural / ascitic / pericardial effusion requiring local intervention or repeated drainage.
• Active autoimmune disease or high-risk history of recurrence; organ transplant with immunosuppression.
• Interstitial lung disease / non-infectious pneumonitis; pulmonary embolism within prior 12 weeks.
• Severe cardio-cerebrovascular events within 6 months; QTcF ≥470 msec; LVEF ≤50%; NYHA ≥III heart failure; history of long-QT syndrome or ongoing QTc-prolonging drugs.
• Uncontrolled hypertension (SBP\>160 mmHg and/or DBP\>100 mmHg) or other uncontrolled systemic diseases.
• High bleeding risk / coagulation disorders: inherited/acquired bleeding-thrombotic predisposition; major bleeding within 3 months; thrombolytics within 10 days; ongoing anticoagulant/antiplatelet therapy (except heparin for CVC patency).
• Immunodeficiency; history of solid-organ or hematopoietic stem-cell transplantation.
• Active TB within past 5 years.
• Severe infection / trauma / GI perforation / fistula / tumor vascular invasion / bowel obstruction within 4 weeks; active infection or antibiotic use within prior 2 weeks (prophylaxis allowed); unexplained fever \>38.5 ℃ (tumor-related fever may be allowed per Investigator judgment).
• Other active malignancy within 3 years, except: cervical carcinoma in-situ, local basal-cell carcinoma, or malignancies cured ≥5 years without recurrence.
• Prior medications \& treatments
• Local radiotherapy completed \<1 week before first dose; \>30% bone-marrow / extensive-field radiotherapy completed \<4 weeks before first dose.

Sponsors & Collaborators

• Parr Biotechnology (Hebei) Co., Ltd.: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130000, China

RECRUITING

Central Study Contacts

Niannian Wang, Project Manager

CONTACT

+86 13161547878; niannian_wang@junshipharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: September 2, 2026
• Study Start: August 17, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)