Can a Tumor-Directed injection shrink Hard-to-Treat cancers?

NCT ID NCT07800936

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This early-stage trial tests an investigational drug called HP007, given as an injection directly into tumors, in adults with advanced solid tumors that have not responded to standard treatments or have come back. The main goals are to check the drug's safety, find the right dose, and see early signs of whether it can shrink tumors. Researchers will monitor side effects and measure tumor response in about 44 participants across several dose levels.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HP007 injection, given directly into the tumor
What this could lead to
If HP007 proves safe and shows antitumor activity, it could become a new treatment option for people with advanced solid tumors that have stopped responding to standard therapies.
What could go wrong
This is an early Phase 1 trial with a small number of participants, focused mainly on safety and dosing. It may not show meaningful tumor shrinkage, and side effects could limit its use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 44 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: 1. 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. 2. Prior medications \& treatments * Local radiotherapy completed \<1 week before first dose; \>30% bone-marrow / extensive-field radiotherapy completed \<4 weeks before first dose. * Anti-tumor therapy within 4 weeks or less than 5 half-lives (whichever shorter). * Systemic corticosteroids (\>10 mg prednisone equivalent/day) or other immunosuppressants within 14 days. * Prior immunotherapy with irAEs ≥Grade 3. * Prior systemic TLR-agonist treatment (topical TLR agonists e.g. imiquimod permitted). * Vaccination within 1 month prior to enrolment. 3. Allergy, general status \& others * Severe hypersensitivity (CTCAE 6.0 ≥Grade 3) to any investigational product component. * Active HBV / HCV, positive syphilis or HIV serology. * Participated in another interventional clinical trial within 4 weeks. * Major surgery within 4 weeks before screening or planned major surgery during study. * Alcohol / illicit-drug / substance abuse within 12 months. * Documented neurological/psychiatric disorders leading to poor compliance. * Pregnant or lactating females. * Subjects judged unsuitable by the Investigator for any other reason.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The First Hospital of Jilin University

    Changchun, Jilin, 130000, China

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