Subjects will receive AK127 by intravenous administration

AK127

After AK127 infusion, on the same day subjects will receive AK104 by intravenous administration

AK104

Baiyong Li

Dennis Xia

A Phase 1 study to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary antitumor activity of AK127 in combination with AK104.

This is a , Phase 1, first-in-human, multicenter, open label, dose escalation and dose expansion study designed to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary antitumor activity of AK127 in combination with AK104 in subjects with advanced and metastatic solid tumours. The study comprises of 2 phases: a dose escalation phase and a dose expansion phase. Dose escalation for AK127 will occur using the 3+3+3 model given with a fixed regimen of AK104. Dose expansion will open at the discretion of the Sponsor.

A Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK127 in Combination With AK104 in Advanced and Metastatic Solid Tumours

A Phase 1a/1b, Multicenter, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Pharmacokinetics, and Anti-tumour Activity of AK127 in Combination With AK104 in Subjects With Advanced or Metastatic Solid Tumours

An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.

DLTs will be assessed during the first treatment cycle and assessed as having a suspected relationship to study drug according to pre-specific criteria in the protocol.

The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.

Progression-free survival is defined as the time from the start of treatment with AK127 + AK104 until the first documentation of disease progression or death due to any cause, whichever occurs first.

Progression-free survival is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first.

Overall survival is defined as the time from the start of treatment until death due to any cause.

The endpoints for assessment of PK including serum concentrations of AK127+AK104 at different timepoints after treatment administration.

The endpoints for assessment of PK of AK127+AK104 include serum concentrations of AK127+AK104 at different timepoints after treatment administration.

The immunogenicity of AK127+AK104 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs).

Akesobio Australia Pty Ltd

LOR-253 HCl will be given in ascending doses until the maximum administered dose or appropriate target dose is reached. A biomarker study of up to 10 patients will be conducted upon achieving appropriate dose level.

LOR-253 HCl will be given in ascending doses starting from 20 mg/m2 until the maximum administered dose or appropriate target dose is reached. Patient will be treated on LOR-253 HCl for 2 cycles for the evaluation.

LOR-253 HCl

Andrea Cercek, M.D.

Jennifer Wheler, MD

This is an open-label, phase 1 study to determine the maximum tolerated dose (MTD) or appropriate target dose if MTD not reached to identify the recommended phase 2 dose of LOR-253 HCl in patients with advanced or metastatic solid tumours.

A Study of LOR-253 HCl in Patients With Advanced or Metastatic Solid Tumours

Open-Label, Phase 1 Study of LOR-253 HCl in Patients With Advanced or Metastatic Solid Tumours

Aptose Biosciences Inc.

All Drugs and Chemicals

Tin Fluorides

Drug:XY0206;Dosage form:Tablet;Dosage：12.5mg;Include single dose treatment and multiple dose phase

Drug:XY0206;Dosage form:Tablet;Dosage：25mg;Include single dose treatment and multiple dose phase

Drug:XY0206;Dosage form:Tablet;Dosage：37.5mg;Include single dose treatment and multiple dose phase

Drug:XY0206;Dosage form:Tablet;Dosage：50mg;Include single dose treatment and multiple dose phase

Drug:XY0206;Dosage form:Tablet;Dosage：75mg;Include single dose treatment and multiple dose phase

Drug:XY0206;Dosage form:Tablet;Dosage：100mg;Include single dose treatment and multiple dose phase

Dosage form:Tablet;Single dose treatment:Take the drug once on day 1,each time 1 tablet. Multiple dose phase:Take the medicine once a day,1 tablet at a time.4 weeks of continuous medication is one course of treatment. After the first course of treatment, the subjects can continue to receive the experimental drug treatment until they meet the criteria for stopping treatment or determine the duration and interval of treatment according to the accumulated condition after multiple dose.

XY0206

wei wang, master

binghe xu, MD

Jinsheng Wu, MD

Da Jiang, MD

Zhanyu Pan, MD

Binghe Xu, MD

1. To observe the safety and tolerability of oral XY0206 in patients with advanced/metastatic malignant solid tumor in China, and observe the drug dose limiting toxicity (DLT) to establish the maximum tolerated dose (MTD) in humans.
2. To investigate the pharmacokinetic (PK) characteristics, pharmacodynamics (PD) characteristics, and PK/PD correlation of single and multiple doses of XY0206 in patients with advanced/metastatic malignant solid tumors to provide dose selection basis for clinical studies;
3. To evaluate the effect of standard meal on main PK parameters of XY0206;
4. To determine the metabolites of XY0206 in patients with advanced/metastatic malignant solid tumor.
5. To explore the correlation between PK and QTcF.
6. Preliminary investigates the effectiveness of XY0206 in patients with advanced/metastatic malignant solid tumors.

A Study of XY0206 in Subjects With Advanced or Metastatic Solid Tumours

A Phase I Open and Multiple Ascending Dose Study to Assess the Safety、Tolerability、Pharmacokinetics and Pharmacodynamic Characteristics of XY0206 in Subjects With Chinese Advanced or Metastatic Solid Tumours

The occurrence rate of adverse drug reactions(ADR).

area under the concentration-time curve from the time of dosing extrapolated to time infinity.

area under the concentration-time curve from the time of dosing extrapolated to the 24h after dosing.

area under the concentration-time curve from the time of dosing extrapolated to the 72h after dosing.

area under the concentration-time curve from the time of dosing extrapolated to the 120h after dosing.

The amount of time that a drug is present at the maximum concentration in serum.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK127 in Combination With AK104 in Advanced and Metastatic Solid Tumours	NCT05021120	Advanced or Met...	AK127 AK104	18 Years -	Akeso
A Study of LOR-253 HCl in Patients With Advanced or Metastatic Solid Tumours	NCT01281592	Advanced or Met...	LOR-253 HCl	18 Years -	Aptose Biosciences Inc.
A Study of XY0206 in Subjects With Advanced or Metastatic Solid Tumours	NCT03658070	Advanced or Met...	XY0206	18 Years - 70 Years	Shijiazhuang Yiling Pharmaceutical Co. Ltd
A Study of XY0206 in Subjects With Advanced or Metastatic Solid Tumours	NCT03658070	Advanced or Met...	XY0206	18 Years - 70 Years	Shijiazhuang Yiling Pharmaceutical Co. Ltd

Spots Global Cancer Trial Database for advanced or metastatic solid tumours