AzTrials
AzTrials

Advanced Solid TumorsPhase 1NCT07622524

A Phase I Study of CS5007 in Participants With Advanced Solid Tumors

A Phase 1 study testing CS5007 in people with Advanced Solid Tumors, run by CStone Pharmaceuticals at 7 sites in 2 countries.

Recruiting

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

Sites and contacts
Official record
Search all trials

Trial summary

This is a first-in-human (FIH), open-label, and multi-center Phase I study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of CS5007 as monotherapy in participants with advanced solid tumors. 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?
CS5007
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
310 participants
Where
7 sitesin 2 countries
Study dates
16 Jul 2026to Jan 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

  • Evidence of a personally signed and dated informed consent document.
  • Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
  • Being ≥ 18 years of age on the day of signing informed consent.
  • Pathologically or cytologically confirmed, unresectable advanced solid tumors.
  • Participants must have at least one measurable lesion according to RECIST Version1.1.
  • Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.
Show all 9Show fewer
  • Adequate organ function.
  • Life expectancy ≥ 3 months.
  • Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 180 days after the last study drug administration

Who cannot join

  • Has disease that is suitable for local treatment administered with curative intent.
  • Has a history of a second malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured.
  • Known primary central nervous system (CNS) tumor or solid tumor CNS metastasis that is symptomatic, untreated, or requires therapy.
  • Has life-threatening bleeding event or severe bleeding within 3 months prior to first dose.
  • Has uncontrolled pleural effusion, pericardial effusion, or ascites.
  • Has immune deficient disease or received systemic immunosuppressive treatment.
Show all 18Show fewer
  • Has intestinal obstruction,or history of inflammatory bowel disease,or chronic diarrhea.
  • Has history of (non-infectious) interstitial lung disease/pneumonitis that required steroids.
  • Has active infections requiring systemic therapy.
  • Has significant cardiovascular disease or cerebrovascular accident within specified timeframes prior to first dose.
  • Insufficient washout from prior anti-tumor therapy.
  • Received live vaccine within 28 days prior to first dose.
  • History of allogeneic organ or hematopoietic stem cell transplantation.
  • History of hypersensitivity to excipients of study drug or any monoclonal antibody.
  • Any toxic effects of prior therapy unresolved to Grade ≤1.
  • Active alcohol or drug abuse.
  • Pregnant or breastfeeding women.
  • Other acute or chronic medical or psychiatric conditions that may increase risk or interfere with study results, in the investigator's judgment.

Trial locations and contacts

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

Sean Yao contact

+86 18616365940

yaosheng@cstonepharma.com

7 sites in 2 countries

Australia6 sites, 6 recruiting

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales, 2010

    Jia (Jenny) Liu

    Not yet recruiting

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

    Melissa Moore

    Not yet recruiting

  • Linear Clinical Research Ltd

    Nedlands, Western Australia, 6009

    Wee Chin

    Recruiting

  • Macquarie University

    North Ryde, New South Wales, 2109

    Wei Yen Chan

    Recruiting

  • Icon Cancer Centre South Brisbane

    South Brisbane, Queensland, 4101

    Jermaine Coward

    Recruiting

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298

    Faisal Hayat

    Recruiting

Other trials in Australia

China1 site, 1 recruiting

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, 200030

    Shun Lu

    Ziming Li

    Not yet recruiting

Other trials in China

About this study

Official title: A Phase I, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti Tumor Activities of CS5007, a Novel EGFR and HER3 Bispecific Antibody-Drug Conjugate, in Participants With Advanced Solid Tumors

This is a first-in-human (FIH), open-label, and multi-center Phase I study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of CS5007 as monotherapy in participants with advanced solid tumors. The study is comprised of a Phase Ia dose escalation and Phase Ib dose expansion.

Being tested
CS5007
Keywords
EGFR, HER3, Bispecific Antibody-Drug Conjugate, Phase I, Advanced Solid Tumors

What participants receive

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

  • CS5007Drug

    CS5007 will be administered via intravenous (IV) infusion on Day 1 of repeated 21-day cycles (Q3W).

Study groups in NCT07622524
Study groupRoleWhat they receive
Dose EscalationExperimentalParticipants will be administered escalating doses of CS5007.
Receives: Drug: CS5007
Dose ExpansionExperimentalParticipants will be administered the recommended dose(s) of CS5007 according to dose-escalation data.
Receives: Drug: CS5007

What is being measured

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

  1. [Dose Escalation] Maximum tolerated dose (MTD) of CS5007

    Participants will receive CS5007 via intravenous (IV) infusion on Day 1 of repeated 21-day cycles (Q3W). The MTD will be determined, if any, by the number of participants who experience a dose limiting toxicity (DLT).

    Measured: Cycle 1 (Up to 21 Days)

  2. [Dose Escalation] Tentative recommended Phase II dose (RP2D) of CS5007

    The selection of tentative RP2D will be based on consideration of overall safety information together with available pharmacokinetic, pharmacodynamic, and efficacy data. The tentative RP2D may be the MTD or a lower dose within the tolerable dose range.

    Measured: Up to approximately 2 years

  3. [Dose Escalation] The incidence and severity of adverse events (AEs)

    Measured: Up to approximately 2 years

  4. [Dose Expansion] Objective response rate (ORR) evaluated by investigators per RECIST v1.1

    Measured: Up to approximately 2 years

Secondary outcomes (13)

  1. [Dose Escalation & Expansion] Area under the curve (AUC) of CS5007

    Measured: Up to approximately 2 years

  2. [Dose Escalation & Expansion] Maximum concentration (Cmax) of CS5007

    Measured: Up to approximately 2 years

  3. [Dose Escalation & Expansion] Time to maximum concentration (Tmax) of CS5007

    Measured: Up to approximately 2 years

  4. [Dose Escalation & Expansion] Elimination half-life (t1/2) of CS5007

    Measured: Up to approximately 2 years

  5. [Dose Escalation & Expansion] Clearance (CL) of CS5007

    Measured: Up to approximately 2 years

  6. [Dose Escalation & Expansion] Volume of distribution (Vz) of CS5007

    Measured: Up to approximately 2 years

  7. [Dose Escalation & Expansion] Trough concentration (Ctrough) of CS5007

    Measured: Up to approximately 2 years

  8. [Dose Escalation & Expansion] Accumulation ratio (R) of CS5007

    Measured: Up to approximately 2 years

  9. [Dose Escalation & Expansion] Number of participants with anti-CS5007 antibodies

    Measured: Up to approximately 2 years

  10. [Dose Escalation] Objective response rate (ORR) evaluated by investigators per RECIST v1.1

    Measured: Up to approximately 2 years

  11. [Dose Escalation & Expansion] Duration of response (DOR) evaluated by investigators per RECIST v1.1

    Measured: Up to approximately 2 years

  12. [Dose Escalation & Expansion] Disease control rate (DCR) evaluated by investigators per RECIST v1.1

    Measured: Up to approximately 2 years

  13. [Dose Expansion] The incidence and severity of adverse events (AEs)

    Measured: Up to approximately 2 years

Timeline

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

  1. First posted3 Jun 2026
  2. Study start16 Jul 2026
  3. Primary completionJan 2028 (estimated)
  4. Study completionJan 2029 (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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
310 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07622524
Sponsor's protocol ID
CS5007-101
Status last verified
Aug 2026
First submitted
28 May 2026
Last updated
14 Aug 2026
Results posted
No
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 CS5007 in people with Advanced Solid Tumors, run by CStone Pharmaceuticals at 7 sites in 2 countries.

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 18 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 14 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 7 sites in Australia, 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 Sean Yao (+86 18616365940, yaosheng@cstonepharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

[Dose Escalation] Maximum tolerated dose (MTD) of CS5007 (time frame: Cycle 1 (Up to 21 Days)). The study lists 4 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 NCT07622524.

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 14 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in