Advanced Solid TumorsPhase 1NCT07053904

Phase I Open-Label Study of P1101 Followed by P1801 in Advanced Solid Tumors

A Phase 1 study testing Sequential use of P1101 and P1801 in people with Advanced Solid Tumors, run by PharmaEssentia at 2 sites in Taiwan.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial summary

The goal of this clinical trial is to learn the safety of sequential treatment with P1101 and P1801 in advanced solid tumors. It will also learn the maximum tolerated dose (MTD) of P1801. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Solid Tumors
What is being tested?: Sequential use of P1101 and P1801
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: 2 sitesTaiwan
Study dates: 21 Apr 2025to 31 Dec 2029
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

Willing to provide written informed consent;
Age ≥18 years;
Patients with histologically or cytologically confirmed metastatic or locally advanced solid tumors who have progressed despite standard therapy or are intolerant to standard therapy or for whom there is no standard therapy;
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1 at trial entry and an estimated life expectancy of at least 3 months;
Dose Escalation Phase: Patients with an advanced solid tumor, including, but not limited to RCC and CRC; Dose Expansion Phase: Patients with RCC or CRC;
Prior chemotherapy or immunotherapy must have been completed at least 4 weeks before screening, and all adverse events have either returned to baseline or stabilized;

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Prior systemic radiation therapy must have been completed at least 4 weeks before screening;
Normal fundoscopic examination by ophthalmologist at screening; major fundoscopic findings including, but not limited to retinal exudates, hemorrhage, detachment, neovascularization, papilloedema, optic atrophy, microaneurysms and macular changes;
Patient who has normal laboratory values relevant to thyroid function.

Who cannot join

Concomitant disease or condition that could interfere with the conduct of the study in the opinion of the Investigator;
Patients requiring chronic treatment with systemic corticosteroids in excess of 10 mg daily of prednisone or equivalent or receiving any systemic immunosuppressive medication will be excluded; while topical, inhaled, nasal and ophthalmic steroids are not prohibited;
Patients with an active autoimmune disease, a documented history of autoimmune disease or syndrome or asthma that requires systemic steroids or immunosuppressive agents;
Untreated or symptomatic brain metastasis;
Subjects with any of the following laboratory test or complications:
Creatinine > l.5 X Upper Limit of Normal (ULN);

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Absolute neutrophil count (ANC) < 1,500/μL;
Platelet count < 100,000/μL;
Hemoglobin < 9 g/dL;
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 X ULN (> 5 X ULN if liver metastasis), or total bilirubin > 1.5 X ULN
international normalized ratio (INR) or activated partial thromboplastin time (aPTT) > 1.5 X ULN;
uncontrolled diabetes mellitus (HbA1c ≥7.4%);
Any presence of poorly controlled major psychiatric (including but not limited to those with severe depression, severe bipolar disorder, schizophrenia, suicidal ideation or history of suicidal attempt);
Any presence of poorly controlled cardiovascular (including but not limited to those with uncontrolled hypertension, New York Heart Association (NYHA) class 2 congestive heart failure, uncontrolled arrhythmia, severe coronary arterial stenosis, unstable angina); or with history of stroke or acute myocardial infarction within 3 years prior to screening;
Female subjects or the spouse of male subjects, with child-bearing potential who are unwilling or unable to practice any highly effective methods of contraception, defined as vasectomy in men, tubal ligation in women, or use of condoms and spermicides, or birth control pills, or intrauterine devices from 28 days prior to Day 1 until the final follow up visit;
Patients who are pregnant, who have a possibility of being pregnant or who desire to become pregnant during the study period;
Lactating women;
History of hypersensitivity reactions to the active ingredients or any excipient of the study drugs; or history of severe hypersensitivity reactions to other monoclonal antibodies;
Use investigational drug of other clinical trials within 4 weeks prior to screening;
History of drug-induced pneumonitis or current pneumonitis;
Active infection requiring systemic antibiotic therapy;
Patients with HBV DNA ≧ 2,000, positive HCV RNA, or known human immunodeficiency virus (HIV) infection;
Patients with Common terminology criteria for adverse events (CTCAE) Grade ≥ 3 cardiac disease or with a history of cardiac arrest;
Receive any vaccination within 4 weeks prior to screening;
Use telbivudine within 4 weeks prior to screening or those will use telbivudine after screening;
Use of prohibited medication or herbal remedies within 4 weeks prior to screening;
History of CTCAE Grade ≥3 immune-related adverse event (AE) that was considered related to prior immune-modulatory therapy or any immune-related AEs that required immunosuppressive therapy.

Trial locations and contacts

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

Taiwan2 sites

Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare
New Taipei City, 23561
Taipei Medical University Hospital
Taipei, 110

Other trials in Taiwan

About this study

Official title: A Phase I, Open-Label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Sequential Treatment With P1101 and P1801 in Patients With Advanced Solid Tumors

To evaluate the safety and tolerability of sequential treatment with P1101 and P1801 in patients with advanced solid tumors.

To determine the maximum tolerated dose (MTD) of P1801.

Participants will:

Ttreated by 6 doses of P1101 once per 2 weeks (Q2W) at 450 mcg and then followed by the treatment with P1801 Q2W at the pre-determined dose level by cohort during each 28-day treatment cycle in the Dose Escalation Phase (Cohort 1-5).

Once the MTD have been declared and for further characterize safety and clinical activity, additional patients with RCC or CRC will be enrolled into the tumor-specific expansion cohorts to receive the sequential administration of 6 doses of P1101 Q2W at 450 ug followed by P1801 Q2W at MTD.

Patients will visit the clinic every two weeks during the treatment period for drug administration and physical examinations.

All patients must complete the safety follow-up visits at the 30-, 90-, and 150-day after the last dose of study treatment.

Upon completion of the safety follow up, patients will be followed for survival every 12 weeks until death or until the end of the study is reached, unless they withdraw consent or are lost to follow-up.

Conditions: Advanced Solid Tumors
Being tested: Sequential use of P1101 and P1801

What participants receive

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

Sequential use of P1101 and P1801Drug
Sequential use of ropeginterferon alfa-2b and P1801 (anti PD-1 antibody drug)

Study groups in NCT07053904
Study group	Role	What they receive
Cohort 1: Sequential 6 doses of P1101 followed by P1801 (0.3 mg/kg, Q2W)	Experimental	Sequential 6 doses of P1101 450 mcg, Q2W; followed by P1801 0.3 mg/kg, Q2W Receives: Drug: Sequential use of P1101 and P1801
Cohort 2: Sequential 6 doses of P1101 followed by P1801 (0.75 mg/kg, Q2W)	Experimental	Sequential 6 doses of P1101 450 mcg, Q2W; followed by P1801 0.75 mg/kg, Q2W Receives: Drug: Sequential use of P1101 and P1801
Cohort 3: Sequential 6 doses of P1101 followed by P1801 (1.5 mg/kg, Q2W)	Experimental	Sequential 6 doses of P1101 450 mcg, Q2W; followed by P1801 1.5 mg/kg, Q2W Receives: Drug: Sequential use of P1101 and P1801
Cohort 4: Sequential 6 doses of P1101 followed by P1801 (2.0 mg/kg, Q2W)	Experimental	Sequential 6 doses of P1101 450 mcg, Q2W; followed by P1801 2.0 mg/kg, Q2W Receives: Drug: Sequential use of P1101 and P1801
Cohort 5: Sequential 6 doses of P1101 followed by P1801 (3.0 mg/kg, Q2W)	Experimental	Sequential 6 doses of P1101 450 mcg, Q2W; followed by P1801 3.0 mg/kg, Q2W Receives: Drug: Sequential use of P1101 and P1801

What is being measured

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

Incidence of Dose-Limiting Toxicities (DLTs)
Incidence of Dose-Limiting Toxicities (DLTs) of P1801
Measured: P1801 treatment cycle is comprised of 2 doses of P1801 administered on Day 1 (CnD1) and Day 15 (CnD15) at each cycle. Eligible patients will be monitored for the occurrence of DLTs during a 28-day period (Cycle 1) after the first administration of P1801.
MTD of P1801
The MTD is defined as the highest dose level at which no more than 1 out of 6 patients experiences a DLT during the 28-day observation period.
Measured: highest dose level at which no more than 1 out of 6 patients experiences a DLT during the 28-day observation period.

Timeline

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

21 Apr 202531 Dec 2029

First posted8 Jul 2025
Study start21 Apr 2025
Primary completion31 Dec 2028 (estimated)
Study completion31 Dec 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
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: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 54 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07053904
Sponsor's protocol ID: C23-101
Status last verified: Jun 2025
First submitted: 27 Jun 2025
Last updated: 8 Jul 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

All Advanced Solid Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Open-Label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Sequential Treatment With P1101 and P1801 in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT07053904
Acronym / sponsor ID: C23-101
Conditions: Advanced Solid Tumors
Phase: Phase 1
Study type: Interventional
Recruitment status: Enrolling by invitation
Enrolment: 54 participants (estimated)
Lead sponsor: PharmaEssentiaIndustry (pharma, biotech, devices)
Collaborators: Efficient Pharma Management Corp.
Study start: 21 Apr 2025 (actual)
Primary completion: 31 Dec 2028 (estimated)
Study completion: 31 Dec 2029 (estimated)
First posted: 8 Jul 2025 (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.

To evaluate the safety and tolerability of sequential treatment with P1101 and P1801 in patients with advanced solid tumors.

To determine the maximum tolerated dose (MTD) of P1801.

Participants will:

Patients will visit the clinic every two weeks during the treatment period for drug administration and physical examinations.

All patients must complete the safety follow-up visits at the 30-, 90-, and 150-day after the last dose of study treatment.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Cohort 1: Sequential 6 doses of P1101 followed by P1801 (0.3 mg/kg, Q2W)	Experimental	Drug: Sequential use of P1101 and P1801Sequential 6 doses of P1101 450 mcg, Q2W; followed by P1801 0.3 mg/kg, Q2W
Cohort 2: Sequential 6 doses of P1101 followed by P1801 (0.75 mg/kg, Q2W)	Experimental	Drug: Sequential use of P1101 and P1801Sequential 6 doses of P1101 450 mcg, Q2W; followed by P1801 0.75 mg/kg, Q2W
Cohort 3: Sequential 6 doses of P1101 followed by P1801 (1.5 mg/kg, Q2W)	Experimental	Drug: Sequential use of P1101 and P1801Sequential 6 doses of P1101 450 mcg, Q2W; followed by P1801 1.5 mg/kg, Q2W
Cohort 4: Sequential 6 doses of P1101 followed by P1801 (2.0 mg/kg, Q2W)	Experimental	Drug: Sequential use of P1101 and P1801Sequential 6 doses of P1101 450 mcg, Q2W; followed by P1801 2.0 mg/kg, Q2W
Cohort 5: Sequential 6 doses of P1101 followed by P1801 (3.0 mg/kg, Q2W)	Experimental	Drug: Sequential use of P1101 and P1801Sequential 6 doses of P1101 450 mcg, Q2W; followed by P1801 3.0 mg/kg, Q2W

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Willing to provide written informed consent;
Age ≥18 years;
Patients with histologically or cytologically confirmed metastatic or locally advanced solid tumors who have progressed despite standard therapy or are intolerant to standard therapy or for whom there is no standard therapy;
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1 at trial entry and an estimated life expectancy of at least 3 months;
Dose Escalation Phase: Patients with an advanced solid tumor, including, but not limited to RCC and CRC; Dose Expansion Phase: Patients with RCC or CRC;

Key exclusion criteria (27 listed)

Concomitant disease or condition that could interfere with the conduct of the study in the opinion of the Investigator;
Patients requiring chronic treatment with systemic corticosteroids in excess of 10 mg daily of prednisone or equivalent or receiving any systemic immunosuppressive medication will be excluded; while topical, inhaled, nasal and ophthalmic steroids are not prohibited;
Patients with an active autoimmune disease, a documented history of autoimmune disease or syndrome or asthma that requires systemic steroids or immunosuppressive agents;
Untreated or symptomatic brain metastasis;
Subjects with any of the following laboratory test or complications:

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
Sequential use of P1101 and P1801Sequential use of ropeginterferon alfa-2b and P1801 (anti PD-1 antibody drug)	Drug	Cohort 1: Sequential 6 doses of P1101 followed by P1801 (0.3 mg/kg, Q2W), Cohort 2: Sequential 6 doses of P1101 followed by P1801 (0.75 mg/kg, Q2W), Cohort 3: Sequential 6 doses of P1101 followed by P1801 (1.5 mg/kg, Q2W), Cohort 4: Sequential 6 doses of P1101 followed by P1801 (2.0 mg/kg, Q2W), Cohort 5: Sequential 6 doses of P1101 followed by P1801 (3.0 mg/kg, Q2W)

Primary outcome

Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: P1801 treatment cycle is comprised of 2 doses of P1801 administered on Day 1 (CnD1) and Day 15 (CnD15) at each cycle. Eligible patients will be monitored for the occurrence of DLTs during a 28-day period (Cycle 1) after the first administration of P1801.
Incidence of Dose-Limiting Toxicities (DLTs) of P1801
MTD of P1801
Time frame: highest dose level at which no more than 1 out of 6 patients experiences a DLT during the 28-day observation period.
The MTD is defined as the highest dose level at which no more than 1 out of 6 patients experiences a DLT during the 28-day observation period.

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 8 Jul 2025.
Individual participant dataSharing planned: No

Related trials for Advanced Solid Tumors

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

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.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Sequential use of P1101 and P1801 in people with Advanced Solid Tumors, run by PharmaEssentia at 2 sites in Taiwan.

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 9 inclusion and 27 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: enrolling by invitation, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Taiwan. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Dose-Limiting Toxicities (DLTs) (time frame: P1801 treatment cycle is comprised of 2 doses of P1801 administered on Day 1 (CnD1) and Day 15 (CnD15) at each cycle. Eligible patients will be monitored for the occurrence of DLTs during a 28-day period (Cycle 1) after the first administration of P1801.). The study lists 2 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 NCT07053904.

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 8 Jul 2025.