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Solid TumorsPhase 1NCT07800936

HP007 Monotherapy for Relapsed or Refractory Advanced Solid Tumors

A Phase 1 study testing HP007 in people with Solid Tumors, run by Parr Biotechnology (Hebei) Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Solid Tumors
What is being tested?
HP007
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteChina
Study dates
17 Aug 2026to 30 Dec 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • 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.
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Niannian Wang, Project Manager contact

+86 13161547878

niannian_wang@junshipharma.com

China1 site, 1 recruiting

  • The First Hospital of Jilin University

    Changchun, Jilin, 130000

    Yanhua Ding, Chief Physician, dingyanh@jlu.edu.cn

    Yanhua Ding, Chief Physician

    Recruiting

Other trials in China

About this study

Official title: Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) Profiles of Intratumoral Injection of HP007 Injection as Monotherapy in Patients With Relapsed or Refractory Advanced Solid Tumors, and to Explore the Preliminary Efficacy of HP007

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
Being tested
HP007

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HP007Drug

    Participate will recepit HP007 monotherpy with 4 dose groups

Study groups in NCT07800936
Study groupRoleWhat they receive
HP007ExperimentalParticipate will recepit HP007 monotherpy with 4 dose groups
Receives: Drug: HP007

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DLT

    Safety endpoints: incidence and severity of DLT

    Measured: up to one year

  2. AE

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

    Measured: up to two years

  3. SAE

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

    Measured: up to two years

  4. MTD

    Maximum tolerated dose (MTD)

    Measured: up to one year

  5. RP2D

    Recommended dose for phase II trial

    Measured: up to one year

Secondary outcomes (20)

  1. ORR

    Efficacy endpoints: Objective response rate (ORR) per RECIST v1.1 or mRecist 1.1 or PCWG3

    Measured: up to two years

  2. DOR

    Efficacy endpoints: Duration of response (DOR) per RECIST v1.1 or mRecist 1.1 or PCWG3

    Measured: up to two years

  3. DCR

    Efficacy endpoints: Disease control rate (DCR) per RECIST v1.1 or mRecist 1.1 or PCWG3

    Measured: up to two years

  4. PFS

    Efficacy endpoints: Progression-free survival (PFS) per RECIST v1.1 or mRecist 1.1 or PCWG3

    Measured: up to two years

  5. OS

    Efficacy endpoints: Overall survival (OS)

    Measured: up to two years

  6. Peak concentration（Cmax）

    The pharmacokinetic parameters of WJ47156：peak concentration (Cmax)

    Measured: up to two years

  7. the time to receive Cmax（Tmax）

    The pharmacokinetic parameters of HP007：the time to receive Cmax (Tmax)

    Measured: up to two years

  8. Area Under the plasma concentration-time curve (AUC0-t, AUC0-∞)

    The pharmacokinetic parameters of HP007 ：area under the plasma concentration-time curve (AUC0-t, AUC0-∞)

    Measured: up to two years

  9. Volume of distribution (Vd)

    The pharmacokinetic parameters of HP007 ：Volume of distribution (Vd)

    Measured: up to two years

  10. Rate of clearance (C)

    The pharmacokinetic parameters of HP007 ：Rate of clearance (CL)

    Measured: up to two years

  11. Terminal half-life (t1/2)

    The pharmacokinetic parameters of WJ47156 ：terminal half-life (t1/2),

    Measured: up to two years

  12. Steady-state peak concentration(Cmax,ss)

    The pharmacokinetic parameters of HP007 ：steady-state peak concentration(Cmax,ss) for the main PK parameters for multiple dose

    Measured: up to two years

  13. Plasma trough concentration at steady state(Cmin,ss)

    The pharmacokinetic parameters of HP007：Plasma trough concentration at steady state(Cmin,ss) for the main PK parameters for multiple dose

    Measured: up to two years

  14. Accumulation ratio for AUC

    The pharmacokinetic parameters of HP007：Accumulation ratio of area-under-the-curve, defined as steady-state AUC within one dosing interval divided by Day 1 AUC (typically AUC₀-₂₄h). It characterizes overall systemic exposure accumulation over the dosing cycle, used for efficacy and total exposure assessment.

    Measured: up to two years

  15. the time to receive Cmax at steady state（Tmax,ss）

    The pharmacokinetic parameters of HP007 ：the time to receive Cmax at steady state（Tmax,ss）for the main PK parameters for multiple dose)

    Measured: up to two years

  16. Area Under the plasma concentration-time curve at steady state (AUC0-t, ss)

    The pharmacokinetic parameters of HP007：area under the plasma concentration-time curve at steady state (AUC0-t, ss)for the main PK parameters for multiple dose)

    Measured: up to two years

  17. ADA

    The incidence and changes of anti-drug antibody (ADA) after treatment were observed

    Measured: up to two years

  18. Nab

    The incidence and changes of neutralizing antibody (Nab) after treatment were observed

    Measured: up to two years

  19. Cytokines

    The changes of serum cytokines (IFN-α, IFN-γ, IL-6, IL-10, and chemokines IFN-γ-inducible protein 10 (IP-10) and TNF-α )in peripheral blood before and after treatment were observed

    Measured: up to one year

  20. Subtype of lymphocyte

    Flow cytometry was used to detect the changes in lymphocyte subsets in peripheral blood before and after treatment

    Measured: up to one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2026
  2. Study start17 Aug 2026
  3. Primary completion30 Dec 2028 (estimated)
  4. Study completion30 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07800936
Sponsor's protocol ID
HP007CH101
Status last verified
Sep 2026
First submitted
26 Aug 2026
Last updated
23 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HP007 in people with Solid Tumors, run by Parr Biotechnology (Hebei) Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Niannian Wang, Project Manager (+86 13161547878, niannian_wang@junshipharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DLT (time frame: up to one year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07800936.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.

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Clinical Trial NCT07800936 | AzTrials