Health TrialsbyHealthPanel

HP007 Monotherapy for Relapsed or Refractory Advanced Solid Tumors

ConditionSolid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorParr Biotechnology (Hebei) Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • HP007

    Drug

    Participate will recepit HP007 monotherpy with 4 dose groups

Treatment groups

44 Participants
are divided into 1 treatment group
Group A: HP007Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

DLT

Safety endpoints: incidence and severity of DLT

Time frame
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

Time frame
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

Time frame
up to two years
4

MTD

Maximum tolerated dose (MTD)

Time frame
up to one year

Secondary outcomes

1

ORR

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

Time frame
up to two years
2

DOR

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

Time frame
up to two years
3

DCR

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

Time frame
up to two years
4

PFS

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

Time frame
up to two years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Parr Biotechnology (Hebei) Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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