Can a Tumor-Directed injection shrink Hard-to-Treat cancers?
NCT ID NCT07800936
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 44 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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The First Hospital of Jilin University
Changchun, Jilin, 130000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a radioactive 'Smart Bomb' target tough tumors?
- Can a new drug shrink advanced solid tumors?
- Can a new pill shrink advanced solid tumors?
- Can a daily pill target hard-to-treat cancers with EGFR or HER2 mutations?
- Can a new gemcitabine formulation outsmart advanced solid tumors?