Solid TumorsPhase 1NCT07591155
A Study of BL-ARC002 in Patients With Locally Advanced or Metastatic Solid Tumors
A Phase 1 study testing BL-ARC002 in people with Solid Tumors, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study is an open-label, multicenter, dose-escalation and expansion, non-randomized Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of BL-ARC002 for injection in patients with locally advanced or metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- BL-ARC002
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 13 May 2026to Dec 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily sign the informed consent form and comply with the protocol requirements;
- No gender restrictions;
- Age: ≥18 and ≤75 years (Phase Ia); ≥18 years (Phase Ib);
- Expected survival time ≥3 months;
- Histopathologically and/or cytologically confirmed locally advanced or metastatic solid tumors that have failed standard treatment;
- Agree to provide archived tumor tissue specimens or fresh tissue samples from the primary or metastatic lesions within the past 2 years;
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- Must have at least one measurable lesion as defined by RECIST v1.1;
- Eastern Cooperative Oncology Group performance status of 0 or 1;
- Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
- No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%;
- Organ function levels must meet the required criteria;
- Coagulation function: International normalized ratio ≤1.5 and activated partial thromboplastin time ≤1.5 × upper limit of normal;
- Urine protein ≤2+ or ≤1000 mg/24 hours;
- For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, with serum pregnancy test being negative, and they must not be breastfeeding; all enrolled patients (regardless of sex) must practice adequate barrier contraception throughout the entire treatment period and for 6 months after treatment completion.
Who cannot join
- Use of chemotherapy, biotherapy, immunotherapy, etc., within 4 weeks or 5 half-lives prior to the first dose;
- History of serious heart disease;
- QT interval prolongation, complete left bundle branch block, or third-degree atrioventricular block;
- Active autoimmune diseases and inflammatory diseases;
- Diagnosis of another malignancy within 5 years prior to the first dose;
- Hypertension inadequately controlled by two antihypertensive medications;
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- History of ILD requiring steroid therapy, current ILD, or ≥ Grade 2 radiation pneumonitis;
- Active symptoms of central nervous system metastasis;
- History of allergy to recombinant humanized or human-mouse chimeric antibodies, or allergy to any excipient component of BL-ARC002;
- Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Cumulative anthracycline dose > 360 mg/m² from prior (neo)adjuvant anthracycline-based therapy;
- Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
- Active infection requiring systemic therapy;
- Participation in another clinical trial within 4 weeks prior to the first dose;
- Pregnancy or breastfeeding;
- Study participants with claustrophobia or any condition preventing them from lying still to complete examinations;
- Other conditions deemed by the investigator to make the participant unsuitable for this clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality
Jihui Hao
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of BL-ARC002 for Injection in Patients With Locally Advanced or Metastatic Solid Tumors
This study is an open-label, multicenter, dose-escalation and expansion, non-randomized Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of BL-ARC002 for injection in patients with locally advanced or metastatic solid tumors.
Read the detailed description
The study consists of two phases: a dose-escalation phase (Phase Ia) and an expansion phase (Phase Ib).
- Conditions
- Solid Tumors
- Being tested
- BL-ARC002
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BL-ARC002Drug
Administration by intravenous infusion for a cycle of 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| BL-ARC002 | Experimental | Participants receive BL-ARC002 for the first cycle (6 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons. Receives: Drug: BL-ARC002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase Ia: Dose limiting toxicity (DLT)
DLTs are assessed according to NCI-CTCAE v5.0 during the first cycle and defined as occurrence of any of the toxicities in DLT definition if judged by the investigator to be possibly, probably or definitely related to study drug administration.
Measured: Up to 42 days after the first dose
Phase Ia: Maximum tolerated dose (MTD)
MTD is defined as the highest dose level at which no more than 1 in 6 participants experienced a DLT during the first cycle.
Measured: Up to 42 days after the first dose
Phase Ib: Recommended Phase II Dose (RP2D)
The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-ARC002.
Measured: Up to approximately 24 months
Secondary outcomes (11)
Treatment-Emergent Adverse Event (TEAE)
TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-ARC002. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-ARC002.
Measured: Up to approximately 24 months
Cmax
Maximum serum concentration (Cmax) of BL-ARC002 will be investigated.
Measured: Up to approximately 24 months
Tmax
Time to maximum serum concentration (Tmax) of BL-ARC002 will be investigated.
Measured: Up to approximately 24 months
T1/2
Half-life (T1/2) of BL-ARC002 will be investigated.
Measured: Up to approximately 24 months
AUC0-t
AUC0-t is defined as area under the serum concentration-time curve from time 0 to the time of the last measurable concentration.
Measured: Up to approximately 24 months
CL (Clearance)
CL in the serum of BL-ARC002 per unit of time will be investigated.
Measured: Up to approximately 24 months
Ctrough
Ctrough is defined as the lowest serum concentration of BL-ARC002 prior to the next dose will be administered.
Measured: Up to approximately 24 months
ADA (anti-drug antibody)
Frequency of anti-BL-ARC002 antibody (ADA) will be investigated.
Measured: Up to approximately 24 months
Phase Ib: Objective Response Rate (ORR)
ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.
Measured: Up to approximately 24 months
Phase Ib: Disease Control Rate (DCR)
The DCR is defined as the percentage of participants who has a CR, PR, or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD]).
Measured: Up to approximately 24 months
Phase Ib: Duration of Response (DOR)
The DOR for a responder is defined as the time from the participant's initial objective response to the first date of either disease progression or death, whichever occurs first.
Measured: Up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start13 May 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by Sichuan Baili Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07591155
- Sponsor's protocol ID
- BL-ARC002-101
- Status last verified
- Aug 2026
- First submitted
- 9 May 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of BL-ARC002 for Injection in Patients With Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT07591155
- Acronym / sponsor ID
- BL-ARC002-101
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
- Study start
- 13 May 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an open-label, multicenter, dose-escalation and expansion, non-randomized Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of BL-ARC002 for injection in patients with locally advanced or metastatic solid tumors.
Detailed description
The study consists of two phases: a dose-escalation phase (Phase Ia) and an expansion phase (Phase Ib).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BL-ARC002 | Experimental | Drug: BL-ARC002Participants receive BL-ARC002 for the first cycle (6 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Voluntarily sign the informed consent form and comply with the protocol requirements;
- No gender restrictions;
- Age: ≥18 and ≤75 years (Phase Ia); ≥18 years (Phase Ib);
- Expected survival time ≥3 months;
- Histopathologically and/or cytologically confirmed locally advanced or metastatic solid tumors that have failed standard treatment;
Key exclusion criteria (17 listed)
- Use of chemotherapy, biotherapy, immunotherapy, etc., within 4 weeks or 5 half-lives prior to the first dose;
- History of serious heart disease;
- QT interval prolongation, complete left bundle branch block, or third-degree atrioventricular block;
- Active autoimmune diseases and inflammatory diseases;
- Diagnosis of another malignancy within 5 years prior to the first dose;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BL-ARC002Administration by intravenous infusion for a cycle of 6 weeks. | Drug | BL-ARC002 |
Primary outcome
Phase Ia: Dose limiting toxicity (DLT)
Time frame: Up to 42 days after the first dose
DLTs are assessed according to NCI-CTCAE v5.0 during the first cycle and defined as occurrence of any of the toxicities in DLT definition if judged by the investigator to be possibly, probably or definitely related to study drug administration.
Phase Ia: Maximum tolerated dose (MTD)
Time frame: Up to 42 days after the first dose
MTD is defined as the highest dose level at which no more than 1 in 6 participants experienced a DLT during the first cycle.
Phase Ib: Recommended Phase II Dose (RP2D)
Time frame: Up to approximately 24 months
The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-ARC002.
11 secondary outcomes
Treatment-Emergent Adverse Event (TEAE)
Time frame: Up to approximately 24 months
Cmax
Time frame: Up to approximately 24 months
Tmax
Time frame: Up to approximately 24 months
T1/2
Time frame: Up to approximately 24 months
AUC0-t
Time frame: Up to approximately 24 months
CL (Clearance)
Time frame: Up to approximately 24 months
Ctrough
Time frame: Up to approximately 24 months
ADA (anti-drug antibody)
Time frame: Up to approximately 24 months
Phase Ib: Objective Response Rate (ORR)
Time frame: Up to approximately 24 months
Phase Ib: Disease Control Rate (DCR)
Time frame: Up to approximately 24 months
Phase Ib: Duration of Response (DOR)
Time frame: Up to approximately 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BL-ARC002 in people with Solid Tumors, run by Sichuan Baili Pharmaceutical 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 14 inclusion and 17 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 27 Aug 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 Sa Xiao, PHD (15013238943, xiaosa@baili-pharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase Ia: Dose limiting toxicity (DLT) (time frame: Up to 42 days after the first dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2026.